A long-term clinical study showed that RELiZORB improves fatty acid absorption in patients suffering from fat malabsorption or pancreatic deficiencies, which is good news for cystic fibrosis (CF) patients suffering from insufficient lipase production.
CF patients often don’t produce enough lipase, a digestive enzyme that catalyzes the breakdown of fats. Lipase is the active ingredient in RELiZORB; this helps break down fat in the enteral formula given to patients, allowing them to absorb 90 percent of the fats present in most enteral feeding tube formulas.
“Fat digestion and absorption is critical to overall patient health,” Dr. Steven Freedman, chief of the Division of Translational Research at Boston’s Beth Israel Deaconess Medical Center, said in a press release. “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 and significant weight loss.”
ASSURE (NCT02750501) is a study designed to evaluate the RELiZORB cartridge, an in-line digestive enzyme cartridge that has already received approval from the U.S. Food and Drug Administration for use in patients to hydrolyze fats in enteral formula.
The 90-day study involved 39 patients aged 5 to 33 at 10 U.S. cystic fibrosis treatment centers.
Patients receiving RELiZORB with overnight enteral formula were found to have improved levels of fatty acid absorption, with their omega-3 index increasing 2.2 times. Patients with abnormal levels of essential fatty acids responded to the treatment by a 2.3-fold increase in the levels of plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) within 30 days of treatment. DHA and EPA are two important fatty acids.
A 1.7-fold decrease in the inflammatory biomarker omega-6 to omega-3 ratio was also observed within the same period.
Patients maintained their body-mass index as well as protein and fat-soluble vitamin absorption over the 90 days of the study. RELiZORB was also found to be safe and well tolerated.
“For patients with cystic fibrosis, current treatment practices do not adequately address fat malabsorption,” said Alcresta CEO Daniel Tassé. “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. 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.”
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