Policy & Regulation
Anji Pharma Completes Patient Enrollment in Phase 2 Study of Pradigastat in Functional Constipation
19 May 2022 - - US-based medicines company Anji Pharma 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 company said.

The trial is being conducted in five clinical sites in the US and 20 clinical sites in China. Anji plans to report topline data from this study in the second half of 2022.

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 at week 4.

The key secondary endpoint is the change from baseline in the number of weekly complete spontaneous bowel movement at week 4.

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.

Anji Pharma is a clinical-stage company dedicated to bringing life-changing therapies to patients across the globe. Anji's asset-centric business model allows for speed and flexibility in building value, leveraging a clinical and regulatory core that operates with "hub-and-spoke" efficiency.

Anji's clinical pipeline includes gut-targeted metformin (ANJ900 in Phase 3) intended for glucose management in patients with type 2 diabetes and advanced chronic kidney disease, as well as pradigastat (ANJ908 in Phase 2) for treatment of functional constipation.
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