Synergy Pharmaceuticals Inc (SGYP) Moves Closer To Expanding Plecanatide Label

Synergy Pharmaceuticals Inc (NASDAQ:SGYP) has provided an update on topline results from a Phase 3 study of its candidate plecanatide. The study evaluated the efficacy and safety of plecanatide as a treatment for irritable bowel syndrome with constipation (IBS-C) in adults.

The study was carried out over a period of 12 weeks in 1,054 patients in the U.S. in a double-blind, placebo-controlled format. Patients received plecanatide in doses of 3mg or 6mg a day during the 12-week period. The control group also received placebo in the same frequency over the same period of time.

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When the 12 weeks were over and the data from the study analyzed, the outcome showed that patients who received plecanatide treatment met the primary endpoint with a statistically significant measure compared to the placebo group.

Expanding The Label

The positive outcome from the Phase 3 trial of plecanatide in IBS-C patients paves the way for Synergy Pharmaceuticals Inc (NASDAQ:SGYP) to expand the treatment label of the drug. Plecanatide is already under review by the FDA as a treatment for chronic idiopathic constipation (CIC) and decision on the ongoing review is expected on January 29, 2017. Synergy plans to make a Supplement New Drug Application (sNDA) for plecanatide as a treatment of IBS-C in 1Q17.

Addressable Market

Expanding the label of plecanatide could yield more sales for Synergy than earlier anticipated. According to data shared by Synergy, up to 5% of the U.S. adult population has IBS-C related complications. That’s a huge addressable market if plecanatide gets regulatory nod for the indication.

Another Candidate In The Pipeline

Synergy Pharmaceuticals Inc (NASDAQ:SGYP) has a rich pipeline. Besides plecanatide, its other late-stage candidate is SP-333 (dolcanatide), which is also targeted at gastrointestinal disease market. SP-333 is being evaluated as a treatment for mild-to-moderate ulcerative colitis in a Phase 1b exploratory study after recently successfully completing a Phase 2 study in patients afflicted by opioid-induced constipation.

Synergy stock rose more than 1% to $5.98 in post-market trading in the last session. The stock earlier slid 0.17% in regular trading. The stock is up more than 4% YTD.

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Note: This article is written by Andy Parker and was originally published at Market Exclusive.