Massachusetts General Hospital (MGH) has enrolled the first patient in an investigator-initiated clinical trial evaluating the efficacy of RELiZORB in managing exocrine pancreatic insufficiency (EPI) in tube-fed pancreatitis patients, Alcresta Therapeutics announced today.
"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.
Understanding EPI and Fat Malabsorption
Exocrine pancreatic insufficiency is characterized by inadequate pancreatic enzyme activity necessary for proper digestion. Fat malabsorption, often associated with EPI conditions including pancreatitis, cystic fibrosis, and gastrointestinal cancers, can result in weight loss and serious gastrointestinal symptoms that significantly impact patient quality of life.
For patients with fat malabsorption who require enteral nutrition, RELiZORB represents a novel approach to improving nutritional outcomes. It is currently the only FDA-cleared enzyme device specifically designed to mimic the function of pancreatic lipase, thereby enhancing the absorption of fats for tube-fed patients.
Clinical Evidence and Expansion
Previous studies have demonstrated that RELiZORB is safe, well-tolerated, and effective in improving fat absorption for patients with cystic fibrosis. This new trial aims to expand the clinical evidence supporting its use in pancreatitis patients.
"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."
RELiZORB Technology and Development
RELiZORB utilizes Alcresta's proprietary enzyme immobilization technology, iLipase®, which binds the digestive enzyme lipase to small polymeric bead carriers. The device connects in-line to enteral feeding systems, allowing the bound lipase to break down formula fats into an absorbable form prior to ingestion.
The FDA initially cleared RELiZORB in 2015 for use in adult patients, with subsequent clearances expanding its use to pediatric patients. Most recently, in January 2025, the device was approved for use in children as young as one year old. A next-generation version of RELiZORB was introduced to the market in May 2024, featuring broader formula compatibility, increased usage capacity per day, and compatibility with both continuous and bolus-feeding setups.
Ongoing Clinical Trials
Alcresta Therapeutics is currently conducting multiple clinical trials to evaluate RELiZORB across various conditions:
- Pancreatitis: NCT06691893
- Short Bowel Syndrome: NCT03530852 and NCT05635747
- Critical Care: NCT05710315
These trials reflect the company's commitment to addressing challenges faced by patients with gastrointestinal disorders and rare diseases who require enteral nutrition support.
Addressing an Unmet Medical Need
Acute pancreatitis represents a significant healthcare burden as one of the leading gastrointestinal causes of hospital admissions. The long-term complications of pancreatitis, including EPI, can substantially impact patient outcomes and quality of life.
For tube-fed patients with pancreatitis who develop EPI, current nutritional management options are limited. The investigation of RELiZORB in this patient population addresses an important unmet medical need and could potentially improve nutritional outcomes for these patients.
Alcresta Therapeutics, headquartered in Waltham, Massachusetts, continues to focus on developing and commercializing novel enzyme-based products for patients with gastrointestinal disorders and rare diseases. The company is backed by Linden Capital Partners and HealthQuest Capital.
