Alcresta Therapeutics Announces Publication of Real-World Evidence Showing Improvements in Growth for Children Ages 1 to 5 Years Old With Use of RELiZORB®

Clinical data published in Nutrients highlights significant improvements in weight and body mass index (BMI) z-scores with use of RELiZORB

WALTHAM, Mass., Jan. 23, 2026 /PRNewswire/ — Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced the publication of real-world evidence results of RELiZORB use demonstrating statistically significant improvements in growth measures for children ages 1 to 5 years old.

“Children who require tube feeding may experience fat malabsorption, which can present challenges to achieving sufficient nutrition. When fat malabsorption is not adequately addressed, it can negatively impact growth and development in pediatric patients,” said Michael Yeh, MD, Chief Medical Officer at Alcresta. “This real-world evidence demonstrates that use of RELiZORB supported improved growth during a critical period of a child’s development.”

This retrospective evaluation assessed the use of RELiZORB in tube feeding regimens among children who initiated RELiZORB use between ages 1 and less than 5 years. The primary endpoint was the change in body weight z-score from baseline (start of RELiZORB) to 12 months and the secondary endpoints were change in BMI z-scores and percentiles from baseline to 12 months, and change in weight z-scores at 3, 6, and 9 months. Use of RELiZORB in this patient population demonstrated statistically significant improvements in mean weight and BMI z-scores from baseline to 12 months, with significant improvements shown as early as 3 months. There were no new safety concerns identified with RELiZORB use in this patient population. About three-fourths of the patients analyzed in this study had cystic fibrosis, and the remaining one-fourth had other malabsorptive conditions, including short bowel syndrome.

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. Previous studies have demonstrated that RELiZORB is safe, well tolerated, and effective in improving fat absorption for patients with pancreatic insufficiency. RELiZORB was recently FDA cleared for use in patients of all ages, expanding the age indication to include neonates and infants. The clearance was supported by a retrospective evaluation of real-world data in neonates and infants aged less than 1 year showing significant improvement in mean weight z-scores at 12 months following initiation of RELiZORB.

“This study builds upon the clinical evidence supporting the use of RELiZORB to improve nutritional care and growth outcomes for pediatric tube-fed patients. The findings further demonstrate the importance of ongoing evaluation of real-world data to inform clinical decision-making and strengthen understanding of nutritional interventions,” said Dan Orlando, Chief Executive Officer at Alcresta.

For access to the publication, visit: Freeman et al. Real-World Evidence of Growth Improvement in Children 1 to 5 Years of Age Receiving Enteral Formula Administered Through an Immobilized Lipase Cartridge (https://www.mdpi.com/2072-6643/18/2/287).

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 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 for adults in 2015, and subsequently expanded the age indication to children as young as 5 in 2017, children as young as 2 in August 2023, and children as young as 1 in January 2025, and for all ages, including neonates in infants in April 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 setups.

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.

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SOURCE Alcresta Therapeutics