CAMBRIDGE, Mass. & SHANGHAI– Anji Pharma, an emerging global medicines company, today announced it has completed enrollment in its Phase 2 proof of concept study of pradigastat (ANJ908), a diacylglycerol acyltransferase 1 (DGAT1) inhibitor, in patients with functional constipation. The trial is being conducted in five clinical sites in the U.S. and 20 clinical sites in China. Anji plans to report topline data from this study in the second half of 2022.
“Achieving full enrollment during a pandemic while ensuring alignment with regulatory expectations of a randomized Phase 2 is a significant endorsement of the Anji development team and our mission to develop programs concurrently in the two largest pharmaceutical markets in the world,” said Greg Dombal, Anji’s Global Head of Development. “We believe the rapid enrollment in the study underscores the unmet medical need in functional constipation in the U.S. and China.”
“Current available treatments for functional constipation have very low response rates and often bring undesired side effects,” said May Li, Anji’s Head of Clinical Operations. “The successful recruitment of this trial is due to our experience working closely with leading hospitals in China and our hub-and-spoke operations based in the U.S. and China.”
The Phase 2 study is a randomized, double-blind, placebo-controlled proof of concept study to assess the efficacy, safety and tolerability of pradigastat in patients with functional constipation. The trial has enrolled over 180 patients, who received one tablet a day of pradigastat 20mg or 40mg, or a placebo. The primary endpoint is the change from baseline in the number of weekly spontaneous bowel movement (SBM) at week 4. The key secondary endpoint is the change from baseline in the number of weekly complete spontaneous bowel movement (CSBM) at week 4. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04620161).
Pradigastat is an inhibitor of diacylglycerol acyltransferase 1 (DGAT1), which plays a key role in the re-assembly of meal triglycerides and acts as a sensor of dietary fat intake. The inhibition of DGAT1 by pradigastat changes the intestinal milieu by raising the level of fatty acids in the gut lumen. This may lead to increased colon motility and water secretion, two necessary attributes for effective constipation therapy. Pradigastat has the potential to markedly improve treatment of functional constipation and irritable bowel syndrome-associated constipation (IBS-C), two prevalent diseases with few effective treatments.
