Alcresta Therapeutics Announces Enrollment of First Patient in Clinical Trial Evaluating Use of RELiZORB in Pancreatitis Patients at Massachusetts General Hospital

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 www.alcresta.com.

Internal Media Contact:
Natalie Bronfin
Alcresta Therapeutics, Inc.
[email protected]
617-431-3600

SOURCE Alcresta Therapeutics, Inc.