#United States #Clinical Trials #Waltham #RELiZORB #Alcresta Therapeutics

Alcresta Therapeutics Starts Clinical Trial for RELiZORB

Alcresta Therapeutics, Inc., a prominent company specializing in novel enzyme-based products, recently announced a significant milestone in its clinical development program. Inova Fairfax Medical Campus has enrolled the first patient in an investigator-initiated clinical trial aimed at evaluating the efficacy of RELiZORB in addressing feeding intolerance among critically ill patients experiencing multi-organ failure.

Understanding Feeding Intolerance in Critical Care

Feeding difficulties are a significant concern for patients in critical care settings. According to Dr. George J. Kasotakis, a Trauma/Acute Care Surgeon at Inova Fairfax Medical Campus, pancreatic dysfunction along with tube feeding intolerance complicates appropriate nutritional intake. This can further contribute to malnutrition, complications, and longer hospital stays for these vulnerable patients.

The Role of RELiZORB

RELiZORB is a pioneering FDA-cleared medical device that mimics the action of pancreatic lipase, which is essential for the absorption of fats in enterally-fed patients. Prior studies have shown that RELiZORB is not only safe but also well-tolerated and effective in enhancing fat absorption for those with pancreatic insufficiency due to conditions like cystic fibrosis. Despite the life-saving aspects of tube feeding, many patients suffer from fat malabsorption, which can lead to gastrointestinal symptoms that ultimately undermine the nutritional benefits of the feeding.

This is particularly critical for critically ill patients suffering from multi-organ failure, as pancreatic dysfunction can hinder their ability to absorb necessary calories vital for recovery.

Expanding the Evidence Base

In addition to the current study on feeding intolerance, Alcresta Therapeutics is also involved in multiple ongoing investigations of RELiZORB's safety and efficacy in other conditions such as short bowel syndrome and pancreatitis. Dr. Michael Yeh, Senior Vice President of Medical Affairs at Alcresta, explains that these studies will help fortify the clinical evidence backing RELiZORB, which aims to enhance nutritional care and improve outcomes for tube-fed patients confronting rare diseases.

A Breakthrough FDA-Cleared Device

RELiZORB is designed specifically to hydrolyze fats in enteral formulas and is appropriate for use among both pediatric and adult patients. The device operates using Alcresta’s proprietary enzyme immobilization technology known as iLipase®. This technology enables RELiZORB to connect inline to enteral feeding systems, allowing the bound lipase to process formula fats into forms that are easier to absorb. Initially cleared for adult use in 2015, RELiZORB has received subsequent expansions in its approved age range, making it available for children as young as one year old effective January 2025.

Alcresta's Commitment

Alcresta Therapeutics is devoted to developing innovative enzyme-based products that solve pressing challenges faced by patients with gastrointestinal disorders and rare diseases. Currently, RELiZORB is marketed for enterally-fed patients grappling with pancreatic insufficiency arising from a variety of health conditions, including cystic fibrosis and short bowel syndrome, where malabsorption is a major issue. Furthermore, Alcresta is actively working on a platform tailored for premature infants treated in NICUs.

For those curious about the clinical trials of RELiZORB, more details can be found at ClinicalTrials.gov.

To Summarize

The commencement of this clinical trial at Inova Fairfax marks a critical step in evaluating RELiZORB's effectiveness in managing nutritional needs for critically ill patients. By focusing on improving feeding tolerance in these individuals, Alcresta Therapeutics aims to enhance recovery outcomes and overall patient care.