WARREN, N.J.--(BUSINESS WIRE)--Alcresta Therapeutics, Inc., a company dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases, presented data for the first time from its ASSURE study. This long-term clinical study evaluated the FDA approved RELiZORB® cartridge, an in-line digestive enzyme cartridge, indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula (EF). Data from the ASSURE study was shared at the North American Cystic Fibrosis Conference that took place November 2-4, 2017 in Indianapolis.
“Fat digestion and absorption is critical to overall patient health. In conditions such as cystic fibrosis, there can be insufficient lipase production by the pancreas. This results in fat malabsorption leading to a deficiency of critical omega-3 fats as well as a spectrum of clinical symptoms, including diarrhea, bloating, nausea to significant weight loss,” said Steven Freedman M.D. Ph.D, Chief Division of Translational Research at Beth Israel Deaconess Medical Center. “The ASSURE study demonstrates the positive benefits of sustained use of RELiZORB in improving absorption of fatty acids and is a solution for both adult and pediatric patients receiving enteral feeding who suffer from fat malabsorption, pancreatic deficiencies, and related illnesses.”
The open label study looked at 39 patients, representing approximately 1% of the cystic fibrosis enteral feeding population, and ranging in age from 5 to 33 (mean age 13.8 years) at 10 U.S. cystic fibrosis treatment centers. The study period was 90 days following a seven-day run-in period. RELiZORB was administered with overnight EF. Pancreatic enzyme replacement therapy (PERT), was used with oral food intake but not with overnight EF. PERT is a combination of lipase, protease, and amylase enzymes derived from pig pancreas to aid in digestion of an oral meal. Nevertheless, there are a number of patients where PERT and oral nutritional intake is not adequate. These patients need to have a tube inserted into their stomach to deliver supplemental feedings overnight. RELiZORB is designed to hydrolyze fats in EF over the entire 6-8 hour enteral feed.
In a population known to have abnormal levels of essential fatty acids, use of RELiZORB resulted in significant increases of DHA and EPA in both plasma and red blood cells. Results from the study demonstrated that fat absorption among patients was significantly improved as shown by a 2.2-fold increase in the omega-3 index (erythrocyte membrane levels of DHA+EPA). Additionally, there was a 2.3-fold increase in plasma levels of DHA+EPA observed as early as 30 days and a 1.7-fold decrease in omega-6:3 ratio, a key biomarker of inflammation. Other important nutrients, including protein and fat-soluble vitamins as well as the patient’s BMI, were maintained over the 90-day study period even in the absence of PERT during their overnight feedings. RELiZORB use was found to be safe and well tolerated.
“For patients with cystic fibrosis, current treatment practices do not adequately address fat malabsorption. The results of the ASSURE trial are important because they show that RELiZORB, which is designed to mimic the function of pancreatic lipase, is normalizing absorption of important omega-3 fatty acids,” said Daniel Tassé, Chief Executive Officer, Alcresta Therapeutics, Inc. “We are pleased that RELiZORB continues to show benefit to patients with cystic fibrosis and we are committed to bringing this innovative product to other patients in need.”
In addition to the ASSURE study, other RELiZORB-related research was conducted and presented by investigators from the Medical University of South Carolina, University of Michigan, and Duke University in partnership with the National Jewish Center in Denver. These retrospective studies looked at a variety of measures.
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. The company uses its proprietary technology platform to support a broad pipeline of products, with an initial focus on pancreatic insufficiency, which results in malabsorption common in cystic fibrosis, digestive cancers, premature birth and other serious diseases.
The Alcresta Therapeutics, Inc. management team has extensive experience in pharmaceutical and nutritional product development. The corporate office is based in Warren, New Jersey and is backed by top-tier investors; Athyrium Capital Management, Bessemer Venture Partners, HealthQuest Capital, Frazier Healthcare, and Third Rock Ventures. More information can be found at www.alcresta.com.