Results of Study 497 of RELiZORB in enteral nutrition shows device improves nutrition- Alcresta Therapeutics

Alcresta Therapeutics has announced data from the landmark clinical Study 497 of RELiZORB, a novel in-line digestive enzyme cartridge designed specifically for use by patients receiving enteral tube feeding who have trouble breaking down and absorbing fats. This study was conducted in pediatric and adult patients with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI) receiving enteral feeding. The absorption of fat was calculated by assessing changes in plasma concentrations over 24 hours of physiologically relevant long-chain polyunsaturated fatty acids (LCPUFAs), such as omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). DHA and EPA are not only sources of energy, but are also essential components of cell membranes, and are integral in maintaining normal development and overall health.

RELiZORB use, compared with administration through placebo, resulted in a statistically significant 2.8 fold improvement in total DHA and EPA absorption. The study also found that RELiZORB use during the administration of enteral nutrition across both pediatric and adult patients with CF and EPI was found to be safe and well tolerated. There was a decrease in the frequency and severity of GI symptoms, particularly stool-related symptoms, associated with fat malabsorption. Importantly, more patients had a preservation of appetite and were able to eat breakfast.

Results of this study indicate that RELiZORB use was safe and well tolerated with a lower frequency and severity of gastrointestinal symptoms as compared to current treatment. These results were presented at the 30th Annual Meeting of the North American Cystic Fibrosis Conference.