Phase 3 study of asimadoline for the treatment of diarrhea-predominant irritable bowel syndrome (DIBS)

Tioga Pharmaceuticals announced that it has dosed its first subject in a Phase 3 clinical trial to evaluate asimadoline for the treatment of patients with diarrhea-predominant irritable bowel syndrome (DIBS). This randomized, double-blind study, referred to as ASMP3001, will enroll 600 D-IBS patients at 120 sites in the U.S. It is the first of two Phase 3 trials being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. ASMP3001 will evaluate the safety and efficacy of twice daily treatment of 0.5 milligrams of asimadoline or placebo. The primary endpoint is a responder analysis measuring pain relief and improved motility. The secondary endpoints of ASMP3001 include additional measurements of abdominal pain, stool frequency, urgency and stool consistency. The trial protocol, as designed under the SPA, is consistent with FDA’s recent Guidance for Clinical Evaluation of IBS Products.

Asimadoline is an orally administered small molecule that is a highly selective, peripherally restricted, kappa opioid receptor agonist.

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