Alcresta Therapeutics Announces Enrollment of First Patient in Clinical Trial Evaluating Use of RELiZORB in Critical Care Patients at Inova Fairfax Medical Campus

WALTHAM, Mass., June 16, 2025 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that Inova Fairfax Medical Campus (Inova) has enrolled the first patient in an investigator-initiated trial evaluating the efficacy of RELiZORB in the treatment of feeding intolerance in critically ill patients with multi-organ failure.

"Pancreatic dysfunction and tube feeding intolerance present challenges to achieving adequate nutrition intake for critically ill patients with multi-organ failure, which can lead to malnutrition, complications, and prolonged hospital stays," stated George J. Kasotakis, MD, MPH, Trauma/Acute Care Surgeon and Surgical Intensivist at Inova Fairfax Medical Campus. "The first patient enrolled in this study marks an important opportunity to evaluate the potential role of RELiZORB in improving feeding tolerance for critically ill patients to enhance their ability to reach their nutritional goals."

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 pancreatic insufficiency due to cystic fibrosis. For patients on tube feeds, feeding intolerance can be associated with fat malabsorption resulting in a variety of gastrointestinal symptoms that can limit the nutritional benefits of tube feeding. Pancreatic dysfunction can prevent critically ill patients with multi-organ failure from efficiently receiving the calories they need to recover.

"In addition to this study, there are currently additional ongoing studies evaluating the safety and efficacy of RELiZORB, including short bowel syndrome and pancreatitis," said Michael Yeh, MD, Senior Vice President of Medical Affairs at Alcresta Therapeutics. "Inova's study will help build upon the clinical evidence supporting the use of RELiZORB to improve nutritional care and outcomes for tube-fed patients living with rare diseases."

For more information about RELiZORB clinical trials, visit ClinicalTrials.gov:

• Critical Care: NCT05710315
• Pancreatitis: NCT06691893
• Short Bowel Syndrome: NCT03530852 and NCT05635747

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.