Exocrine Pancreatic Insufficiency

WALTHAM, Mass., April 29, 2025 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that Massachusetts General Hospital (MGH) has enrolled the first patient in an investigator-initiated trial evaluating the efficacy of RELiZORB in managing exocrine pancreatic insufficiency (EPI) in tube-fed pancreatitis patients. "We are excited about the enrollment of the first patient in this study to evaluate the potential benefits of RELiZORB use in tube-fed pancreatitis patients. Acute pancreatitis is one of the leading gastrointestinal causes of hospital admissions, and there is a growing focus on managing long-term complications of pancreatitis, which includes EPI," said Casey Luckhurst, MD, Pancreatic and General Surgeon and Inpatient Director of Massachusetts General Hospital's Pancreatitis Treatment Center. Fat malabsorption is often associated with EPI conditions including pancreatitis, cystic fibrosis, and gastrointestinal cancers and can result in weight loss and serious gastrointestinal symptoms. For patients with fat malabsorption who require tube feeding, RELiZORB is the only FDA-cleared enzyme device designed to mimic the function of pancreatic lipase to improve absorption of fats for tube-fed patients. Studies have demonstrated that RELiZORB is safe, well-tolerated, and effective in improving fat absorption for patients with cystic fibrosis. "The initiation of study recruitment marks an important step toward expanding the body of clinical evidence that supports RELiZORB use in Alcresta's target therapeutic areas," said Michael Yeh, MD, Senior Vice President of Medical Affairs at Alcresta Therapeutics. "This is one of four clinical trials evaluating the safety and efficacy of RELiZORB in malabsorptive conditions supporting our mission to improve nutritional care and outcomes for tube-fed patients living with rare diseases." For more information about RELiZORB clinical trials, visit ClinicalTrials.gov: Pancreatitis: NCT06691893 Short Bowel Syndrome: NCT03530852 and NCT05635747 Critical Care: NCT05710315 About RELiZORB®  (iMMOBILIZED LIPASE) CARTRIDGE RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase and is indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula. RELiZORB was developed using Alcresta's proprietary enzyme immobilization technology, iLipase®, which is the digestive enzyme lipase bound to small polymeric bead carriers. RELiZORB connects in-line to enteral feeding systems. As enteral formula passes through RELiZORB, the bound lipase breaks down formula fats into an absorbable form prior to ingestion. RELiZORB was FDA-cleared in 2015 for use in adult patients and was cleared in 2017 for use in children as young as five years old. Use was expanded to pediatric patients as young as two years old in August 2023 and expanded again for patients as young as one year old in January 2025. The next-generation RELiZORB device was introduced to market in May 2024 with broader formula compatibility, an increase in the number of devices used per day and use in both continuous and bolus-feeding set ups. About Alcresta  Therapeutics, Inc. Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases. Alcresta currently markets RELiZORB for enterally-fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer, and pancreatitis, and short bowel syndrome, which is marked by significant malabsorption due to limited absorptive area as a result of resection. Alcresta is currently developing a platform application for prematurely born infants treated in the NICU. Alcresta Therapeutics, Inc. is backed by Linden Capital Partners and HealthQuest Capital. More information can be found at . Internal Media Contact: Natalie Bronfin Alcresta Therapeutics, Inc. [email protected] 617-431-3600 SOURCE Alcresta Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Seracal™, based on Lym-X-Sorb®, contains a proprietary lipid technology invented by David Yesair Ph.D. and exclusively licensed by Vytala DOWNINGTON, Pa., March 18, 2025 /PRNewswire/ -- Vytala, a healthcare-focused food technology company, today announced a series of key achievements signifying commercial momentum and early market leadership. Following the launch of Seracal in November, monthly sales growth has exceeded 50%, driven by strong clinician interest, patient need, and broad coverage by US healthcare insurers. Continue Reading Seracal Logo (PRNewsfoto/Vytala) Dr. Debora Duro, Program Director, Pediatric Gastroenterology, Hepatology and Nutrition at Broward Health, has prescribed Seracal to multiple patients and shares: "Seracal is amazing. I have patients with diagnoses ranging from intestinal failure to faltering weight, and most have experienced weight gain within the first month. Parents are overjoyed, the product is easy to use, and children are gaining weight after months of struggle." Market demand for Seracal has surpassed initial forecasts with a 90% reorder rate – further confirming strong patient acceptance and sustained clinical adoption. Seracal was recently approved by 3 HealthWell Foundation disease funds within Vitamins and Supplements*. This partnership expands access and provides support for patients starting on their Seracal journey. Seracal is an improved formulation that contains the underlying technology of Lym-X-Sorb, a pioneering nutritional therapy invented by Dr. David Yesair of BioMolecular Products, Inc. that addresses fat malabsorption. Seracal/Lym-X-Sorb was proven to be efficacious and well-tolerated in patients with exocrine pancreatic insufficiency and cystic fibrosis in a large $7 million National Institutes of Health sponsored clinical study. Subjects randomized to Seracal/Lym-X-Sorb experienced improved BMI, as demonstrated by increases in both weight and height velocity. The therapy also improved absorption of essential fatty acids, fat-soluble vitamins and choline. Vytala signed an exclusive worldwide licensing agreement with BioMolecular Products (BMP), gaining rights to Lym-X-Sorb's proprietary formulation and extensive manufacturing trade secrets. Over $30 million dollars has funded development of the Lym-X-Sorb technology to date. Vytala has made further formulation enhancements, incorporating key taste, texture and stability improvements into Seracal. A patient with pancreatic cancer describes his experience with Seracal: "I have gained between 8-10 pounds since starting Seracal 6 weeks ago. I believe it has also helped with my chronic pancreatitis, lessening the symptoms of belly pain and back pain. This has allowed me to widen my diet to include foods that I couldn't eat previously." Vytala is actively enrolling subjects into an IRB approved study designed to assess Seracal's acceptance and clinical outcomes across a broader patient populations. Led by Dr. Carol Ireton-Jones PhD, RDN, CNSC, FASPEN, FAND, an esteemed expert in gastrointestinal nutrition with numerous publications - the multi-center study will measure GI symptoms, weight gain and nutrient absorption in at least 30 patients aged one and older. Swapna, a healthcare advocate, researcher and adult living with Short Bowel Syndrome, conveyed her excitement about being one of the first patients to enroll in the study: "Living a fulfilling life with tube feeding due to congenital Short Bowel Syndrome, I have always had to be at the mercy of innovation. Participating in Vytala's early experience program, I can finally be at the forefront of science. I hope Seracal will be the easy and accessible answer to my reduced ability to absorb fat and fat-soluble nutrients, a barrier I have had for 35 years. Maybe I can even live to eat and enjoy nourishing myself with food without all the complications! A goal I have only dreamed of." Dr. Ireton-Jones commented, "Anecdotal data provides insight into patient experiences, but in the scientific community, research is essential to generate evidence. That is why we're conducting this study. We are confident that Seracal's unique technology will improve fat absorption in patients with a variety of GI conditions, which is why this study is so important." Seracal is available nationwide and is covered by most healthcare insurers. *Approved for Alagille Syndrome, Cystic Fibrosis, and Inborn Errors and Genetic Bile Acid Deficiency About Vytala Vytala is advancing nutrition with a mission to help people achieve their best health through the power of nutrition. Our founding team is committed to addressing the widespread problem of malabsorption and brings over 100 years of experience in clinical nutrition, food science, healthcare and in reimbursement. Vytala's unique crystalized lipid technology has been proven in multiple clinical studies, and CMS has issued a new reimbursement code for the product. Vytala is developing a suite of precision nutrient products to address a broad spectrum of diseases in humans and animals. The company will not rest until it has eliminated nutrient deficiencies. SOURCE Vytala WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BOCA RATON, Fla., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Entero Therapeutics, Inc. (Nasdaq: ENTO) (“Entero” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that the board of directors has appointed Mr. Richard Paolone as the interim CEO of the Company. Richard Paolone is a Toronto-based securities lawyer with extensive experience in corporate finance, securities law, and mergers and acquisitions. Mr. Paolone plays a key role in advising on a range of strategic business initiatives and has represented numerous companies in both private and public offerings of debt and equity securities, comprehensive understanding of capital markets and regulatory environments. His advisory work has been pivotal to several successful M&A and go-public transactions. In addition to his transactional work, Mr. Paolone has built a reputation as a trusted advisor to management teams and boards, ensuring legal and regulatory compliance in Canada while facilitating business growth. His broad experience also includes serving as a director or officer for several private and publicly traded companies, where he continues to provide strategic insights and governance expertise to help guide their success in competitive markets. For more information about Entero Therapeutics, visit www.enterothera.com and connect on X and LinkedIn. About Entero Therapeutics Entero Therapeutics, Inc., is a late clinical-stage biopharmaceutical company focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company’s programs address significant unmet needs in GI health and include: latiglutenase, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist for indications including gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. For more information visit www.enterothera.com. For more information:Entero Therapeutics, Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561) 589-7020info@enterothera.com Investor contact information:Entero Investor Relationsinvestors@enterothera.com