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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

WALTHAM, Mass., Jan. 15, 2025 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that the U.S. Food and Drug Administration (FDA) has cleared expanded use of RELiZORB® for children down to age 1 year old. RELiZORB is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase. The expanded indication for ages 1 and above is based on a retrospective evaluation of real-world data in patients aged 1 to 2 years old who utilized RELiZORB in enteral formula as part of their nutrition routine. No additional safety concerns were identified with RELiZORB use in this younger patient population. "Receiving clearance for children ages 1 and above signifies another meaningful milestone for RELiZORB and enterally fed patients with fat malabsorption," said Dan Orlando, Chief Executive Officer at Alcresta Therapeutics. "Since its commercial availability in May 2024, our second-generation cartridge has expanded use, specifically to patients with short bowel syndrome (SBS), helping address the essential nutritional needs for these patients and many other patients living with rare diseases. We are excited that the expansion of RELiZORB's indication will help to further expand access, especially in younger populations where nutritional goals associated with growth and development are vitally important." About RELiZORB® (iMMOBILIZED LIPASE) CARTRIDGE RELiZORB is indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula. RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is 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. 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

LOS ANGELES, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PRX-P4-003, a gut-activated stimulant, to treat apathy in Alzheimer’s Disease. Previously, an exploratory microdose clinical trial in healthy volunteers demonstrated successful activation of PRX-P4-003 upon oral administration, the intended therapeutic route. “Apathy remains one of the most frequently observed symptoms in the Alzheimer’s Disease with no FDA-approved therapy,” stated Jeffrey Cummings, MD, ScD, director of the Chambers-Grundy Center for Transformative Neuroscience and Professor of Brain Sciences at the University of Nevada Las Vegas, “PRX-P4-003 has chemical properties and preliminary clinical validation that support its potential to build upon the pioneering studies in treating apathy led by the NIH-funded ADMET group.” PRX-P4-003, a selectively bioavailable dopamine and norepinephrine reuptake inhibitor, is a new chemical entity discovered by Praxis Bioresearch. The compound was designed to be activated by pancreatic lipase, an enzyme that is only present in the digestive system. “This is an important milestone for us,” said Sandeep Patil, MD PhD, CEO/Cofounder of Praxis Bioresearch, “I am particularly proud of our team in successfully delivering a high-quality IND package. In the next phase of development, we are deeply committed to demonstrating the effectiveness of our compound in improving the symptoms of apathy in the clinical trials." About PRX-P4-003 PRX-P4-003 is a new chemical entity developed by Praxis Bioresearch that delivers an active isomer of fencamfamine. Fencamfamine is a Schedule IV stimulant that was originally developed and marketed by E. Merck KG, located in Darmstadt, Germany. This prodrug, unlike current stimulants such as methylphenidate and amphetamines, is designed to only be orally active potentially decreasing the risk of abuse. There is a medical need for alternatives to current Schedule II stimulant medications in neuropsychiatric indications as diversion is a significant concern. About Apathy in Alzheimer’s Disease Apathy is the most prevalent neuropsychiatric symptom of Alzheimer’s dementia, affecting nearly 71% of patients over the course of the disease. Apathy has been associated with patient suffering, caregiver distress, and excess disability. There is no approved treatment for apathy in Alzheimer’s Disease. Disclaimer: Research reported in this publication was supported in part by the National Institute of Aging of the National Institutes of Health under Award Number R44AG066378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Contact: info@praxisbioresearch.com