Synergy Pharmaceuticals ($SGYP) reported positive results in its second Phase 3 clinical trial assessing plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C). The company announced that the trail met its primary endpoint of a statistically valid overall responder (OR) rate versus placebo at week 12.
The outcomes of the study confirmed the positive results from the first Phase 3, which was announced two weeks ago. The company seeks to file a supplemental New Drug Application for ISB-C in the first quarter of the year.
Synergy Pharmaceuticals has already filed the NDA seeking approval for plecanatide to treat chronic ideopathic constipation. The application is currently being reviewed by the FDA and the result is likely to be announced by January 29.
Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals said, “We are understandably very pleased with these results, and how well the data support the first pivotal phase 3 IBS-C trial which we announced recently.”
The company had recently reported its third quarter results. Its net loss for the quarter stood at 22 cents per share. The total net loss for the quarter was reported at $40.2 million. However, with the latest developments, the company stock is likely to show good movements in the future.