Tioga Pharmaceuticals, Inc. announced today that the company 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). The trial, referred to as ASMP3001, is the first of two Phase 3 trials being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for U.S. registration. This first trial will be conducted at 120 sites in the U.S.
ASMP3001 will enroll 600 D-IBS patients to evaluate the safety and efficacy of twice daily treatment of 0.5 milligrams of asimadoline or placebo. The primary endpoint of the randomized, double-blind clinical study 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.
"In the Phase 2b study, asimadoline was shown to significantly improve both pain and abnormal motility in D-IBS patients with at least moderate pain," said Allen Mangel, M.D., Ph.D., consulting Chief Medical Officer for Tioga Pharmaceuticals. "The millions of patients suffering from this condition in the U.S. have very limited therapeutic options, illustrating a high unmet medical need Tioga is seeking to address."
Currently there is only one drug approved in the U.S. for D-IBS patients, but due to safety concerns its use is restricted to patients with severe cases and it is administered under a risk management program.
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