Synergy Pharmaceuticals Inc. SGYP announced that it has started the second pivotal phase III study on plecanatide in patients suffering from irritable bowel syndrome with constipation (IBS-C). Two once-a-day doses – 3.0 mg and 6.0 mg – will be evaluated in this study.
The two randomized, 12-week, double-blind, placebo-controlled studies are being conducted in the U.S. in adult patients (n=1050 in each trial) with IBS-C. The first study IBS-C was initiated in Dec 2014.
While top-line data from the first IBS-C trial should be out in the fourth quarter, the second study data should be out in the first half of 2016. The new drug application (NDA) for the IBS-C indication could be filed in the second half of 2016.
We note that Synergy Pharma is also evaluating plecanatide for the treatment of patients with chronic idiopathic constipation (CIC). Earlier this month, Synergy Pharma reported positive top-line data from the first of the two pivotal studies being conducted for the CIC indication. The company intends to report data from the second pivotal study in the first half of the third quarter of 2015 with an NDA filing expected in the fourth quarter.
Synergy Pharma, which is focused on the development of novel therapies to traet gastrointestinal (GI) diseases and disorders, has another late-stage candidate in its pipeline – SP-333. SP-333 has successfully completed a phase II study in patients with opioid-induced constipation and is currently in a phase Ib exploratory study in patients with mild-to-moderate ulcerative colitis.
Currently approved treatments for IBS-C include Linzess and Amitiza.
Synergy Pharma currently carries a Zacks Rank #2 (Buy). Gilead Sciences Inc. GILD, Hospira Inc. HSP and INSYS Therapeutics, Inc. INSY are also well-placed stocks in the health care sector carrying a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment