Synergy Pharmaceuticals Inc. (SGYP) announced positive top-line results from a phase II study (n=289) on its opioid-induced constipation (OIC) candidate, SP-333. The candidate met the primary objective of the study.
The study evaluated the safety, efficacy and dose-response of oral SP-333 tablets (1.0, 3.0 and 6.0 mg) compared to placebo in patients suffering from OIC.
Results from the study revealed that the 3.0 and 6.0 mg dose groups of SP-333 showed a statistically significant improvement in mean change from baseline in the number of spontaneous bowel movements (SBMs) as compared to placebo during week 4 of the treatment period.
The candidate was also safe and well tolerated. The company reported that two patients from the 6.0 mg dose group of SP-333 withdrew from the study because of diarrhea.
Our Take
Results from the mid-stage study on SP-333 were encouraging. SP-333 is also being evaluated for the treatment of mild to moderate ulcerative colitis in a phase Ib study.
We believe more than SP-333, investors focus is most likely to stay on Synergy Pharma’s lead candidate, plecanatide. Synergy Pharma is currently evaluating plecanatide in two phase III studies for the treatment of chronic idiopathic constipation (CIC). Top-line data from these studies are expected in the second quarter and third quarter of 2015 respectively.
Plecanatide is also being developed for the treatment of irritable bowel syndrome (IBS) with constipation. Synergy Pharma plans to start a phase III study in this indication by the end of 2014.
Ironwood Pharmaceuticals/Actavis’ (IRWD/ACT) Linzess is a well-known product in the gastrointestinal market.
Synergy Pharma currently carries a Zacks Rank #3 (Hold). Valeant Pharmaceuticals International, Inc. (VRX) with a Zacks Rank #1 (Buy) is a better-ranked stock in the health care sector.
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
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment