Alcresta Therapeutics has reported data from the clinical study 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 trial was carried out 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 not only serve as sources of energy, but are also essential elements of cell membranes, and are integral in maintaining normal development and overall health.
RELiZORB use, compared with administration through placebo, led to a statistically significant 2.8 fold improvement in total DHA and EPA absorption.
The trial 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 frequency and severity of GI symptoms, especially stool-related symptoms, associated with fat malabsorption. More patients had a preservation of appetite and were able to eat breakfast.
Alcresta Therapeutics CEO Daniel Tassé said: "We are very pleased and excited about the results of this landmark study.
"RELiZORB is the only product that is FDA cleared for patients using enteral nutrition and who have fat malabsorption, and therefore addresses a critical unmet medical need."
Safety and efficacy of RELiZORB was analysed in a multicentre, prospective, randomised, double-blind, cross-over study, conducted in 33 patients with EPI due to CF.
Patients enrolled in the trial ranged from 5 to 34 years of age and had received enteral nutrition for an average of 6.6 years.
Changes in fatty acid plasma concentrations of physiologically relevant LCPUFA omega-3 fats such as DHA and EPA were analysed over 24 hours, reflecting the uptake of fat in enteral formula due to use of RELiZORB with enteral feeding.
The study's results show that RELiZORB use was safe and well tolerated with a lower frequency and severity of gastrointestinal symptoms as compared to present treatment.
RELiZORB use with enteral formula also led in a 2.8 fold statistically significant increase in DHA and EPA fatty acids.
Absorption bolstered irrespective of age.
RELiZORB use was also associated with a greater preservation of appetite when compared to current treatment practice.