Alcresta Therapeutics Begins First Clinical Trial Patient Enrollment for RELiZORB in Pancreatitis at MGH

Alcresta Therapeutics Begins Clinical Trial for RELiZORB

Alcresta Therapeutics, a pioneer in enzyme-based therapies, has recently announced a significant advancement in their clinical research endeavors. They have officially enrolled the first participant in a clinical trial evaluating the use of their innovative product, RELiZORB, to assist patients suffering from exocrine pancreatic insufficiency (EPI), specifically within the context of tube feeding for those with pancreatitis. This trial is held at the prestigious Massachusetts General Hospital (MGH).

RELiZORB is a unique enzyme cartridge developed to replicate the action of pancreatic lipase, effectively aiding in the breakdown and absorption of fats in patients who require enteral nutrition. This device is especially crucial for those with EPI, a condition where the pancreas fails to release sufficient digestive enzymes, leading to challenges such as fat malabsorption, weight loss, and a host of intestinal complications.

Dr. Casey Luckhurst, an esteemed pancreatic and general surgeon serving as the Inpatient Director at MGH's Pancreatitis Treatment Center, shared his enthusiasm about this trial. According to him, "The enrollment of our first patient highlights the potential benefits of RELiZORB for tube-fed pancreatitis patients. Given that acute pancreatitis ranks among the primary gastrointestinal causes of hospital admissions, addressing its long-term complications, such as EPI, is imperative."

The significance of RELiZORB cannot be understated, especially in light of its FDA clearance, which confirms its safety and efficacy in enhancing fat absorption for patients, including those with conditions like cystic fibrosis and various gastrointestinal cancers. For patients on tube feeding, the ability to adequately absorb fats is crucial to preventing malnutrition and associated health issues.

Dr. Michael Yeh, Senior Vice President of Medical Affairs at Alcresta Therapeutics, emphasized that this trial is part of a larger strategy to enrich the body of clinical evidence supporting RELiZORB. "This is one of four clinical trials being conducted to assess the safety and effectiveness of this device across several malabsorptive conditions," Dr. Yeh explained. "Our mission is clear—to improve nutritional care and outcomes for patients relying on tube feeding, especially those coping with rare diseases."

The RELiZORB device works seamlessly within enteral feeding systems, allowing for the hydrolysis of fats in the provided formulas. The process involves the enzyme lipase, which, once bound to a small polymer bead within the cartridge, enables the breakdown of fats into more absorbable forms. Since its FDA clearance in 2015, RELiZORB has undergone expansions to cater to a younger demographic, now approved for patients as young as one year old as of early 2025.

Alcresta Therapeutics remains committed to developing innovative solutions for patients facing gastrointestinal challenges. Their broader mission includes ongoing research and development aimed at improving outcomes for persons with conditions such as pancreatic insufficiency and short bowel syndrome. These initiatives are supported by significant investments from entities like Linden Capital Partners and HealthQuest Capital, which underscores the potential and promise seen in the company's technologies.

As this clinical trial progresses, it could mark a transformative moment not only for RELiZORB but also for the future of nutritional therapies in managing complex gastrointestinal conditions.

For more details about the ongoing clinical trials related to RELiZORB, you can visit ClinicalTrials.gov and explore studies including those focused on pancreatitis (NCT06691893) and other related conditions.

With mounting evidence from various studies showcasing RELiZORB's efficacy in real-world applications, there is a palpable sense of optimism about the future, both for the patients who stand to benefit and for the healthcare professionals advocating for their needs.