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.
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 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 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.
