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PathAI's AISight Dx Image Management System is CE Marked for Primary Diagnosis

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that its AISight Ⓡ Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis. The CE mark paves the way for the company's expansion in the European diagnostic pathology market, enhancing pathologists' interpretations and driving efficiencies and quality improvements within anatomic pathology laboratories. "The IVDR certification demonstrates PathAI’s unwavering commitment to providing safe, effective, and high-quality diagnostic solutions," said Andy Beck, MD, PhD, co-founder and CEO of PathAI. "It not only confirms the compliance of our AISight platform with the latest European regulations but also strengthens our ability to assist pathologists in delivering accurate diagnoses and improving patient outcomes across Europe." AISight Dx is a robust digital pathology platform meticulously designed with input from over 200 pathologists to streamline end-to-end digital pathology workflows. It offers a suite of features including best-in-class caseload balancing and assignment, image ingestion, image viewing, collaboration tools, and image and case management. The platform can also seamlessly integrate bi-directionally with laboratory information systems through AISight Link, further enhancing workflow efficiency. Anatomic pathology laboratories of all sizes and specialties – including health systems, university hospitals, and reference laboratories – can leverage the benefits of AISight. "We are thrilled to expand our focus to bring the AISight Dx Image Management System to European labs. We look forward to partnering with European labs to democratize access to digital pathology, enhance the pathologist experience, and ultimately improve patient outcomes," said Nick Brown, Chief Growth Officer at PathAI. PathAI will be exhibiting at the European Congress of Pathology from September 7 to 11, 2024. To learn more about AISight and see a demo, visit us at booth #L145 or email digitaldx@pathai.com. About PathAI PathAI is a leading provider of integrated AI and digital pathology solutions, dedicated to transforming diagnostic accuracy and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

August 28, 2024 03:00 AM Eastern Daylight Time

AGC Biologics Strengthens Portfolio with Latest FDA Commercial Approval at Copenhagen Facility

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the newest milestone at its Copenhagen Campus, a U.S. Food and Drug Administration (FDA) commercial approval for a biosimilar indicated for psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. This is the latest commercial biosimilar approval for the global CDMO, and a new milestone for its Copenhagen site. The expiration of patents for biologics products is driving new players to enter the biosimilar market and offer lower-cost alternatives for patients. Market value for this drug segment is expected to be more than $126 billion by 2032, a 17.6 percent CAGR between 2023 and 2032, according to a 2023 report. AGC Biologics offers key resources for biosimilar developers, such as flexible and scalable single-use manufacturing technology, the ability to scale production based on market demand, and strong expertise in managing quality control requirements needed to advance in each clinical phase. All these characteristics led to AGC Biologics’ Copenhagen site guiding this new product to FDA commercial approval. “We have one of the most extensive single-use technology bioreactor networks in the world. This allows us to start with the 2,000 L scale for product launch and scale out and utilize added vessels to reach larger batch sizes of 4,000 L, 6,000 L, 8,000 L etc. based on product demand in later phases. Through this economies-of-scale production model, we increase production for biosimilars as demand grows, while saving costs for our partners,” said Christoph Winterhalter, Chief Business Officer, AGC Biologics. “When you combine this element with our scientific quality expertise that emphasizes finding the Quality Target Product Profile (QTPP) – we are one of the best CDMOs available to help biosimilar developers meet clinical and commercial goals.” “This latest FDA achievement at our site demonstrates why we have been so successful,” notes Andrea Porchia, General Manager, AGC Biologics Copenhagen. “I continue to be impressed by this site and our team’s commitment to quality, productivity, and helping partners achieve their goals. We look forward to helping to produce this important treatment and providing patients in need with a new option to choose from other than what has been historically available.” The new commercial approval in the U.S. for this product comes after the AGC Biologics Copenhagen site announced the completion and opening of a new manufacturing building at its site in June, which more than doubled its single-use bioreactor capacity. The new 19,000 m2 ultramodern building offers a larger manufacturing floor, expanded quality control and process development lab space, and added utilities to support all operations at the site. AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems and has a gold EcoVadis Sustainability Rating for its environmental, health, and sustainability practices. To learn more about AGC Biologics’ protein biologics manufacturing site in Copenhagen, visit https://www.agcbio.com/facilities/copenhagen. For more information on the company’s end-to-end global CDMO services in Europe, Japan, and the U.S. visit www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

August 28, 2024 12:05 AM Mountain Daylight Time

Hospital and Health System M&A Remains Active in 2024, Reports Benchmark International

Benchmark International

Benchmark International, a leader in the mergers and acquisition (M&A) industry, has released its latest insights on the hospital and health system M&A landscape, revealing that merger and acquisition activity within the sector remains robust as the healthcare industry continues to navigate challenges and seize opportunities in 2024. According to Benchmark International’s latest report, the dynamics driving M&A activity in the healthcare sector include the need for increased operational efficiency, access to capital, and the pursuit of growth through strategic partnerships. Despite economic headwinds and ongoing regulatory scrutiny, the firm notes that many health systems are actively seeking consolidation opportunities to enhance their competitive positioning, expand service offerings, and ensure long-term sustainability. The report highlights several notable transactions in 2024, demonstrating the diverse motivations behind M&A deals, from scale-driven acquisitions to partnerships focused on expanding access to care. Benchmark International emphasizes that these trends are likely to persist as health systems continue to seek innovative ways to address the evolving demands of the healthcare landscape. As a trusted advisor with extensive experience in the healthcare sector, Benchmark International continues to guide clients through the complexities of M&A transactions, providing strategic insights and support to help them achieve their goals. For more information and to access the full article, please visit https://www.benchmarkintl.com/insights/2024-hospital-and-health-system-ma-remains-active/ ABOUT BENCHMARK INTERNATIONAL: Benchmark International is a global M&A firm that provides business owners with creative, value-maximizing solutions for growing and exiting their businesses. Benchmark International has handled over $11 billion in transaction value across various industries from offices across the world. With decades of M&A experience, Benchmark International’s transaction teams have assisted business owners with achieving their objectives and ensuring the continued growth of their businesses. The firm has also been named the Investment Banking Firm of the Year by The M&A Advisor and the Global M&A Network as well as the #1 Sell-side Exclusive Privately-held M&A Advisor in the World by Pitchbook and Refinitiv's Global League Tables. Contact Details Brittney Zoeller +1 813-898-2350 zoeller@benchmarkintl.com Company Website https://www.benchmarkintl.com/

August 27, 2024 09:00 AM Eastern Daylight Time

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The Potential Of Ketamir-2: A Safer Treatment For Mental Health Disorders And Neuropathic Pain, IND Filing Expected By Year-End

Benzinga

By Meg Flippin, Benzinga Treating mental health is constantly evolving, bringing new therapies and hope to people battling depression, treatment-resistant depression (TRD), post-traumatic stress disorder (PTSD) and other neuropsychiatric conditions. Not all therapies work for everyone, but sometimes an exciting treatment emerges. Ketamine, originally developed as an anesthetic, falls into that category. In recent years, it has been repurposed as a rapid-acting antidepressant, particularly for patients who have not responded to conventional treatments. While often effective, ketamine’s widespread use has been limited by its side effects and low oral bioavailability. Traditional ketamine requires intravenous or intranasal administration, which can be inconvenient and impractical for at-home treatment. Additionally, ketamine’s interaction with multiple receptor sites in the brain can lead to unwanted side effects such as dissociation, hallucinations and, in some cases, psychotic symptoms. Tweaking Ketamine But that doesn’t mean ketamine has to be written off as a new treatment for mental health. It just needs to be tweaked. That’s where MIRA Pharmaceuticals (NASDAQ: MIRA) and Ketamir-2 come in. A pre-clinical-stage pharmaceutical company, MIRA is refining this treatment with its oral ketamine analog, Ketamir-2. MIRA Pharmaceuticals says Ketamir-2 is a groundbreaking compound that has the potential to revolutionize the way mental health disorders and neuropathic pain are treated, offering a safer and more effective alternative to traditional therapies. The company is on track to file an Investigational New Drug (IND) application by the end of the year, marking what it says is a significant milestone in bringing Ketamir-2 closer to clinical trials. Ketamir-2 is designed to overcome the challenges of existing ketamine treatments by creating an agent that is more targeted. Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site with 30 to 50 times lower affinity than traditional ketamine. This selective inhibition can reduce the risk of dissociation and hallucinations, providing a cleaner, safer therapeutic experience for patients. Preclinical studies have so far found that Ketamir-2 offers a superior safety profile compared to traditional ketamine. MIRA Pharmaceuticals said one of the most significant findings is that Ketamir-2 does not induce hyper-locomotor activity – a behavior associated with psychotic symptoms – making it a potentially safer option for patients. Better Oral Absorption Could Be Game-changing Another discovery MIRA Pharmaceuticals reports, is Ketamir-2’s non-substrate status for P-glycoprotein (P-gp), a membrane protein that typically limits drug entry into the brain. This means that Ketamir-2 can more effectively cross the blood-brain barrier, leading to better oral absorption and higher efficacy at lower doses. This feature is particularly important for patients seeking convenient, at-home treatment options. On top of all that, MIRA Pharmaceuticals says Ketamir-2’s principal metabolite, Nor-Ketamir, boasts nearly 100% oral bioavailability and sustained plasma residence. This means that once Ketamir-2 is administered orally, it is efficiently metabolized into Nor-Ketamir, which remains in the bloodstream longer, providing extended therapeutic effects. The development of Ketamir-2 Pamoate, a new salt form, further enhances these benefits by ensuring higher plasma and brain levels with a longer half-life, reports the company. Treating Chronic Pain Too Beyond depression and mental health issues, MIRA Pharmaceuticals said studies are ongoing to assess Ketamir-2’s effectiveness in treating neuropathic pain, a chronic and debilitating condition that has an estimated prevalence of 6.9% to 10% worldwide. The dual potential of Ketamir-2 to address both mental health disorders and neuropathic pain could represent a significant advancement in patient care, offering a versatile and effective treatment option. The potential of Ketamir-2 and Nor-Ketamir to offer effective, at-home treatment options for mental health disorders and neuropathic pain could prove to be a game-changer. The convenience of oral administration, combined with the drug’s safety and efficacy, could significantly improve patient adherence to treatment and overall outcomes. Further, the company says toxicology studies have validated Ketamir-2’s safety profile, with no observed toxicity at very high doses in animal models. Ketamine holds a lot of promise in treating mental health but the side effects are limiting adoption. Ketamir-2 could change that by addressing the limitations of traditional ketamine and offering a safer, more effective alternative. If the preclinical trials are any indication, Ketamir-2 could provide hope for many sufferers. For more information about MIRA Pharmaceuticals and its novel compounds, visit MIRA Pharmaceuticals. Featured photo by nikko macaspac on Unsplash Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 27, 2024 08:50 AM Eastern Daylight Time

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Minerva Surgical Launches Next Generation Symphion Fluid Management Accessory with Fluid Deficit Readout

Minerva Surgical, Inc.

Minerva Surgical, a manufacturer and distributor of minimally invasive gynecologic surgical technologies, today announced the launch of the Symphion Fluid Deficit Readout, an optional accessory that provides fluid deficit volume readings during operative hysteroscopy procedures. Operative hysteroscopy is a surgical procedure that requires precise fluid management to prevent complications. The Symphion Fluid Deficit Readout, which is intended for use with the Symphion Operative Hysteroscopy System, automatically calculates the fluid deficit during the procedure by measuring the weight of the saline bag throughout the procedure in real time and converting the weight measurement into fluid volume readings. Additional key features of the Symphion Fluid Deficit Readout include a fluid deficit accuracy within +/- 50mL, a user-friendly interface with an intuitive display for easy operation, and a compact design that allows for quick set up with the Symphion controller. “Continuous innovation with a focus on enhancing patient safety has always been the primary objective for Minerva Surgical. The Symphion Operative Hysteroscopy System is intended to volumetrically limit a patient’s exposure to fluid so the risk of fluid absorption and overload can be avoided. With the introduction of the Symphion Fluid Deficit Readout, the system has a new layer of procedural safety to complement the unprecedented precision during uterine cavity tissue resection.”, states Minerva Surgical Chief Medical Officer Eugene Skalnyi, M.D. Along with the Symphion Fluid Deficit Readout, Minerva Surgical is launching a compatible, next generation of Fluid Management Accessory called INFINITY. Together, the Symphion line extensions are the newest additions to the Minerva Surgical portfolio of minimally invasive technologies. The company is committed to advancing gynecologic surgery and providing solutions that enhance outcomes. About Minerva Surgical, Inc. Minerva Surgical is a technology enabled medical device company focused on developing, manufacturing, distributing, and commercializing minimally invasive solutions to meet the distinct pelvic healthcare needs of women. The Company has established a broad product line of minimally invasive alternatives to hysterectomy, which include solutions to detect and address common causes of Abnormal Uterine Bleeding (AUB). The Minerva Surgical pelvic health solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the anatomy by avoiding unnecessary hysterectomies. For more information about the innovative medical devices of Minerva Surgical, please visit www.MinervaSurgical.com. Contact Details Kevin Tracey +1 855-646-7874 kevin.tracey@minervasurgical.com Company Website https://minervasurgical.com/

August 26, 2024 10:00 AM Eastern Daylight Time

Theriva Biologics Receives Rare Pediatric Drug Designation From FDA For Treatment Of Retinoblastoma

Benzinga

By Kyle Anthony, Benzinga The growing prevalence of cancer is not limited to adults; it is also afflicting children. An estimated 15,780 children between birth and 19 years of age are diagnosed with cancer each year in the U.S., according to the American Childhood Cancer Organization. Approximately 1 in 285 children in the U.S. will be diagnosed with cancer before their 20th birthday. Globally, there are more than 300,000 children diagnosed with cancer each year, and the rate of childhood cancer is slowly rising; cancer cases increased to 177 per million in 2019 from 165 per million in 2003. Recently, Theriva Biologics (AMEX: TOVX), the clinical-stage immuno-oncology company developing therapies for difficult-to-treat cancers, was granted Rare Pediatric Drug Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for VCN-01 for the treatment of retinoblastoma; the most common type of eye cancer in children. Retinoblastoma Presents Significant Treatment Challenges Retinoblastoma is a tumor that originates in the retina and accounts for approximately 2% of all childhood cancers. Some 200 to 300 children are diagnosed each year in the U.S., and the cancer is most common among infants and young children. The average age of a child when diagnosed is two years of age. Approximately three out of four children with retinoblastoma have a tumor in only one eye (known as unilateral retinoblastoma). When both eyes are affected it is known as bilateral retinoblastoma. Although the chances of developing retinoblastoma are statistically low, the challenge of preserving life while preventing the loss of an eye, blindness, and other severe consequences that diminish both lifespan and quality of life remains significant. Furthermore, in low-resource countries, children with retinoblastoma face a higher risk of losing their eyes and succumbing to metastatic disease. Recently, market research and industry consulting firm Spherical Insights assessed the global retinoblastoma treatment market size to be $2.5 billion in 2023; and it is expected to grow to $3.8 billion by 2033. Rare Pediatric Drug Designation For VCN-01 As the name suggests, the Rare Pediatric Drug Designation is a special status given to drugs explicitly developed for treating rare diseases that affect children. This designation is part of a broader effort to encourage the development of medications for conditions not commonly addressed due to the small number of patients, particularly in the pediatric population. For Theriva Biologics, this designation comes with a key incentive: if a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA, Theriva says it may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed to receive a priority review for any subsequent marketing application or may be transferred or sold. PRVs have previously been sold by different companies for around $100M. “The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma. We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma,” said Steven A. Shallcross, CEO of Theriva Biologics. “Most recently, results from the investigator-sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Data from this study will further inform our clinical development pathway in this area of high unmet need,” he said. With VCN-01 receiving RPDD from the U.S. FDA, this milestone speaks to the drug's efficacy and long-run potential. As such, the social benefit that Theriva Biologics provides could continue to grow and have increased industry resonance. Featured photo by Ani Kolleshi on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 26, 2024 08:45 AM Eastern Daylight Time

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Poster Presentations, Upcoming Human Trials, Recently Secured Funding And More: Glucotrack’s Plans To Transform The Continuous Glucose Monitoring Market

Benzinga

By Meg Flippin, Benzinga Managing diabetes has gotten an overhaul thanks to continuous glucose monitoring devices (CGM). Glucotrack Inc. (NASDAQ: GCTK), the Rutherford, New Jersey medical technology company that makes a continuous blood glucose monitoring (CBGM) device, is seeking to position itself to transform the glucose monitoring market. It is doing so through what it says is a game-changing medical technology that overcomes the challenges of the existing devices on the market, including the lack of real-time accuracy, the need for frequent sensor changes and concerns regarding comfort and wearability. Glucotrack’s implantable Continuous Blood Glucose Monitor (CBGM) measures glucose in the blood, something no other known competitor is offering to date. By measuring glucose in the blood instead of glucose in interstitial fluids – which is what most other devices measure – users get an accurate, real-time reading. Plus, Glucotrack’s implant can last up to three years, compared to less than one year for many of the continuous glucose monitoring (CGM) devices on the market. Patients don’t have to worry about sticking an adhesive to their body or be concerned about it falling off during physical activity, whether it's swimming or hot yoga. The CBGM, which also requires minimal calibration, eliminates the hassle and discomfort of a wearable that requires frequent replacement, the company said. Making The Rounds Glucotrack has been busy getting the word out about the potential of its CBGM. In June, it presented two posters at the American Diabetes Association (ADA) 84th Scientific Sessions discussing preclinical animal studies and a sensor longevity simulation modeling for its CBGM. The ADA Scientific Sessions is one of the premier diabetes conferences which provides a platform for the latest advancements in diabetes research, prevention and care. This annual meeting provides researchers and healthcare professionals with the opportunity to share ideas and learn about cutting-edge technologies and breakthroughs in diabetes research and diabetes-related conditions. Glucotrack also presented an emerging science industry poster at the Association of Diabetes Care and Education Specialists annual conference, which took place from Aug. 9 to 12. The poster presented market research data on the acceptance of the company’s CBGM concept among people with type 1 and type 2 diabetes. It highlighted that out of 757 respondents with type 1 and type 2 diabetes using a variety of insulin regimens, there was a positive sentiment towards the CBGM concept, with over 50% of potential users open to adopting the product. In other words, the CBGM concept could be a viable alternative to existing products on the market. PreClinical Trials In The Bag Glucotrack’s data so far seems to back up its claims, including its recent 90-day preclinical study demonstrating the sustained accuracy of its CBGM. The second long-term preclinical study for its CBGM showed a Mean Absolute Relative Difference (MARD) of 4.7% at day 90, which is considered highly accurate for a continuous glucose monitor, reports Glucotrack. MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device’s measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance, said Glucotrack. The company said the 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM’s sustained accuracy and performance. “We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials,” stated Paul Goode, PhD, president and CEO of Glucotrack. “Our CBGM’s ability to continuously measure blood glucose for 3 years with accuracy, minimal calibration and without a wearable device represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution,” he said. Cashing In All of these developments seem to have brought Glucotrack investment money; in July, the company secured $4 million in funding from its leading shareholder to support its upcoming first in-human clinical trial. It also helps the company that it has a deep leadership bench and board with years of experience. Take Goode, for starters. He has decades of experience developing innovative medical technologies in the implantables and glucose monitoring space for big-name medical technology companies, including DexCom Inc. (NASDAQ: DXCM), a global continuous glucose monitoring company. Goode is a named inventor on over 150 issued patents, including over 100 relating to Dexcom’s continuous glucose sensing technology. Meanwhile, Mark Tapsak, Ph.D., VP of Sensor Technology, has held senior positions at diabetes management companies, including as senior scientist at DexCom. Further, the bench just got deeper with the appointment of Andy Balo – a former DexCom executive – to the board. Balo brings decades of regulatory, clinical and quality experience in the medical technology industry. In 2002, he joined DexCom as part of the original executive team where he remained for the next 22 years, playing a key role in shaping the company’s future. During his tenure, he was responsible for numerous glucose monitoring regulatory submissions and clinical trials worldwide, and coordinated quality activities across multiple manufacturing facilities. With a forecasted CAGR of 10.3% over 2024-2034, the continuous glucose monitoring market could be poised to take off, and Glucotrack wants to play a role in expanding options for patients with its technology. With preclinical trials already being in the bag, and human trials up next - the company feels its commitment to that goal is progressing steadily toward fruition. Featured photo by Mykenzie Johnson on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 26, 2024 08:30 AM Eastern Daylight Time

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RedHill's Opaganib Shows Diabetes And Obesity Potential With Positive In Vivo Results

Benzinga

By Meg Flippin, Benzinga A potential, previously unexplored pathway for fighting diabetes and obesity-related disorders may have been unveiled by RedHill Biopharma (NASDAQ: RDHL), a specialty biopharmaceutical company, and its partner Apogee Biotechnology Corp., who are busy developing what may be an interesting new approach in the obesity and diabetes market. The company is testing opaganib in a range of metabolic disease models designed to show its potential to prevent and treat type 2 diabetes and other obesity-related diseases and recently received positive in vivo results. The positive results of early trials are good news for RedHill Biopharma given the global obesity-diabetes drug market opportunity is huge, projected to reach $100 billion by 2030. It’s being driven largely by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk’s (NYSE: NVO) Ozempic and Wegovy (semaglutide), Eli Lilly’s (NYSE: LLY) Trulicity (dulaglutide) and Mounjaro (tirzepatide) and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim’s Jardiance (Empagliflozin), reports RedHill. If RedHill is right about opaganib, it could join those ranks. “Sphingolipid metabolism is implicated in insulin resistance, β-cell disruption, adipocyte function, inflammation and immune regulation, vascular complications and energy metabolism – all significant components of obesity, diabetes and their associated complications,” said Charles D. Smith, Ph.D. Founder and CEO of Apogee Biotechnology Corp., Redhill’s partner who led the testing of opaganib for the treatment and prevention of type 2 diabetes and other obesity-related disorders. “Opaganib’s ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for evaluation of opaganib in obesity-related disorders.” Opaganib Slows Weight Gain Earlier this week RedHill announced that in vivo studies conducted by RedHill’s partner, Apogee, yielded positive results. The studies looked at the impact opaganib had on weight gain and glucose tolerance in a high-fat diet (HFD) model. They demonstrated opaganib suppressed HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders, reports RedHill Biopharma. “Sphingolipid metabolism is a key pathway in many diseases, including obesity, but has not been adequately examined as a therapeutic target for human therapy,” said Dr. Mark Levitt, Chief Scientific Officer at RedHill. “Opaganib, which acts as a sphingosine competitor, is the first clinical drug to target three key enzymes in this pathway.” With multiple U.S. government collaborations ongoing, opaganib, RedHill Biopharma’s first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity, is a host-directed, potentially broad-acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection. More Than Fighting Diabetes But it’s not just in fighting diabetes and obesity-related disorders where RedHill is making progress. Adding to its commercialization by RedHill in the U.S., the company just launched Talicia (omeprazole magnesium, amoxicillin and rifabutin) in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori ( H. pylori ) infection. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori. The commercial launch of Talicia in the UAE triggers RedHill’s eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In a pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). “As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern,” said Rick Scruggs, President & Chief Commercial Officer at RedHill. “With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies, there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners.” From preventing diabetes and obesity-related diseases to fighting H. pylori, RedHill Biopharma seems to be making strides with its key drug compounds. Early testing shows promise, potentially making this a company worth watching. To learn more about RedHill Biopharma’s pipeline, click here. Featured photo by Diana Polekhina on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 23, 2024 08:30 AM Eastern Daylight Time

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News Release

Sector Spotlight: Top 4 Basket of Diagnostic Stocks (EXAS, GH, ILMN, LUDG)

LUDG EXAS GH ILMN

Big diagnostic companies soared during the pandemic thanks in part to mandated government testing, but once the at-home kits arrived and insurance companies were forced to foot the bill, diagnostic companies with COVID-19 revenues collapsed. Many diagnostic companies got caught in the downdraft because they thought the testing gravy train was going to continue and ramped up capacity instead of diversifying. The opportunity in the sector comes from diagnostic companies that chose to reinvent themselves by developing early cancer screening tests. During the pandemic, regular cancer screenings were put off to conserve medical resources toward COVID. Since the pandemic is over, it's worth reexamining beat-up diagnostic companies that were able to adapt and are now on the upswing. The top diagnostic stock to put on your radar is Exact Sciences (NASDAQ: EXAS). Most investors will recognize their at-home cancer screening kit is called cologuard which tests for colon cancer. Those primetime commercials you’ve likely heard mean they’ve established their brand along with a national audience. Testing volume dropped measurably during the pandemic as early cancer screening was pushed aside, but now their testing volumes are ramping back up and helping chew through the testing backlog created by the pandemic. It has taken a couple of years for EXAS testing volumes to return to pre-pandemic levels. In Q2 2024 the company had a record 1.0 million screenings and got back on its growth trajectory, helped by an expansion of cancer indications that include breast, prostate, and colon cancer. It also started its pipeline expansion into precision oncology. EXAS also made a move into a blood-based multi-cancer space when they purchased Thrive Early Detection Corp. for $2.15 billion. This purchase turned into a business vertical that not only does a deeper dive into the hereditary nature of the cancer but also profiles the tumor in such a way that it assists in the optimization of treatment regimens. The company has $2.6 billion in trailing revenues and a current market cap of $10.3 billion and is an overall leader in the diagnostic sector with solid earnings and a balance sheet for risk averse shareholders looking for a solid return from a company that consistently beats expectations. Guardant Health Inc. (NASDAQ: GH) has the first FDA-approved primary screening blood test for colorectal cancer (CRC). The test is called Shield and it is covered under the Medicare reimbursement program. Shield has a sensitivity of 83% and a 90% specificity (false positives) for advanced neoplasia (polyps that could turn cancerous). The company has $600 million in trailing revenues and a current market cap of $4.0 billion. They call it a non-invasive test, but you still have to get pricked. Another way to play the diagnostic market is to look at the top industry suppliers. llumina Inc. (NASDAQ: ILMN) is a medtech company that makes genetic testing equipment that enables the large-scale analysis of genetic variations. The company manufactures next-generation sequencing (NGS) platforms, microarrays, and bioinformatics software. Their machines are used in genomics research, clinical applications, and molecular diagnostics, which means their customers are research centers, pharma companies, academic institutions, and clinical research organizations. The company recently spun off their diagnostics business called Grail Inc. (NASDAQ: GRAL) which is an early cancer screening company for people that are not symptomatic, enabling a proactive approach to diagnosing cancer earlier. ILMN funded GRAL with a one-time cash payment of $923 million. The company's leading product is a multi-cancer early detection blood test called Galleri. The test screens for 50+ types of cancer by reading the DNA sequence. The backbone of the testing technology is from the Illumina platform and over 20,000 participants in large clinical trial studies. The test kits cost around $1100 each, and they are awaiting FDA approval for the test. Investors looking for a little more alpha should look at this diagnostic testing company disruptor and its game changing technology. Ludwig Enterprises Inc. (OTCMKTS: LUDG) is an exceptional OTC company in the diagnostic screening sector, boasting mRNA testing technology that has the potential to revolutionize the multibillion-dollar diagnostic screening industry with its less invasive tests. CEO Marvin S. Hausman MD stated, “mRNA is the language that interprets DNA and is the future of medicine.” Although the company currently has no revenue, it is gearing up for an exciting product launch in October, coinciding with Breast Cancer Awareness Month, which is expected to kickstart its revenue stream. To spearhead its viral marketing campaign, the company has enlisted a seasoned veteran. LUDG’s Lab Developed Test (LDT) will initially target breast cancer screening, but the technology can be easily adapted to other inflammatory-driven cancers. These LDTs are processed at the Genetics Institute of America, a CLIA lab, which allows for quicker product launches as they do not require FDA approval. The company has developed a unique cancer screening approach by measuring mRNA at the nucleotide level. Their test uses AI algorithms to create a personalized inflammatory index, comparing it to a database of over 3,200 mRNA samples collected from 40+ clinical centers over five years. This method, particularly for breast cancer, boasts a 97% test sensitivity, indicating when further evaluation is needed. The LUDG test kits will cost $249 and will follow proven successful direct-to-consumer viral marketing strategies driven by targeted machine learning algorithmic technologies. The CEO of LUDG Hausman has come out of retirement to lead this technology to commercialization. He is a Medical Doctor, Immunologist, and board certified Urological Surgeon. Investors in LUDG will have an experienced CEO at the helm with a proven track record of successful exits. One of his most notable exits was when he sold his NYSE company Medco Research to King Pharmaceuticals, which was ultimately acquired by Pfizer (NYSE: PFE). LUDG’s Revealia breast cancer test is very much like the EXAS Cologuard test. As investors move back into diagnostic stocks, these 4 represent a diversified basket every investor should put on their radar. Disclaimers: RazorPitch Inc. 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August 23, 2024 06:00 AM Eastern Daylight Time

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