Alcresta Therapeutics Announces Preclinical Data Evaluating RELiZORBneo Cartridge Use in Neonatal Murine Model of Necrotizing Enterocolitis

Preclinical data published in PLOS ONE highlight potential safety benefit of RELiZORBneo

WALTHAM, Mass., May 1, 2026 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced publication of preclinical data from a study on the use of the company's RELiZORBneo (an immobilized lipase cartridge) product in development.  The study evaluated whether RELiZORBneo would reduce mortality and disease severity in a murine model of necrotizing enterocolitis (NEC) compared to placebo. Results from the study, conducted at Boston Children's Hospital, showed that use of RELiZORBneo to hydrolyze the fats in enteral formula demonstrated a potential safety benefit by modulating the severity of NEC.

RELiZORBneo is a smaller version of RELiZORB®, which has been on the market since late 2015.  RELiZORB has demonstrated safety and improved fat absorption in clinical and preclinical studies of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), as well as preclinical studies in short bowel syndrome (SBS). RELiZORBneo, once cleared by FDA, will support tube-fed individuals who require small volumes, slow flow rates, and frequent feeding schedules, aligning with the enteral nutrition needs of neonates and infants. Neonatal pancreatic immaturity often leads to inadequate lipase levels resulting in low absorption of fats, which plays a critical role in meeting caloric requirements for growth and for proper development of the brain and nervous system.

Published data from a neonatal murine model of necrotizing enterocolitis suggest that pre-digesting fats in enteral nutrition may reduce NEC severity by limiting inflammation triggered by undigested triglycerides.¹ Building on this earlier research, Alcresta's study found that enteral nutrition pre-hydrolyzed by RELiZORBneo was associated with statistically significant improvements in clinical sickness, gross intestinal appearance, and histologic severity scores compared to placebo. Survival and weight outcomes showed numerical differences favoring RELiZORBneo versus placebo. However, these differences were not statistically significant, limiting interpretation in this short-duration, exploratory model.

"We appreciate the collaboration of the distinguished team at Boston Children's Hospital led by Mark Puder, M.D., PhD; a world-leading expert in SBS and parenteral and enteral nutrition," said Greta Loring, Vice President of Research and New Product Development. She added, "Alcresta is excited about the progress being made in the development of RELiZORBneo. The results of this study support our hypothesis that pre-digesting fats in enteral nutrition with RELiZORBneo confers potential safety benefits."

For access to the full text of the study publication, Wang SZ, et al., A digestive cartridge reduces intestinal injury in a murine model of necrotizing enterocolitis, visit https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0348200.

About RELiZORB® (iMMOBILIZED LIPASE) CARTRIDGE
RELiZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding. RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB uses 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.

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 neonates and infants. Alcresta Therapeutics, Inc. is backed by Linden Capital Partners and HealthQuest Capital. More information can be found at www.alcresta.com. 

Disclosure: Mark Puder, M.D., PhD has previously consulted for Alcresta Therapeutics, Inc.

References:

1.  Sodhi CP, Fulton WB, Good M, Vurma M, Das T, Lai CS, et al. Fat composition in infant formula contributes to the severity of necrotising enterocolitis. Br J Nutr. 2018;120(6):665-80. doi: 10.1017/s0007114518001836.

Media Contact:
Corey Starke
Alcresta Therapeutics, Inc.
[email protected]
617-431-3600

SOURCE Alcresta Therapeutics