Synergy Pharmaceuticals recently presented positive results from a phase IIb/III study on its chronic idiopathic constipation (CIC) candidate, plecanatide. The study met its primary objective along with other key objectives.
The results also showed that plecanatide was well tolerated. Synergy Pharma enrolled 951 patients suffering from CIC across 113 clinical sites in the US for the phase IIb/III study.
The study was designed to evaluate plecanatide (0.3, 1.0, 3.0 mg doses) in increasing the number of complete spontaneous bowel movements (CSBM's) along with the impact of other parameters in CIC patients. The study showed that the 3mg dose of the candidate demonstrated a 19% (p=0.009) overall responder rate compared to 10.7% in placebo.
We remind investors that the CIC market is highly competitive with the presence of players like Forest Laboratories Inc. and Ironwood Pharmaceuticals (IRWD - Analyst Report).
We note that last week Synergy Pharma initiated a phase IIb study with plecanatide for the treatment of patients suffering from constipation-predominant irritable bowel syndrome (IBS-C). The trial will be evaluating the average change in CSBMs during the trial period in comparison to their baseline weekly CSBM rate that was established during the screening phase of the study.
Additionally, Synergy Pharma recently completed a phase I clinical trial on SP-333, a guanylate cyclase C (GC-C) agonist, being developed for the treatment of ulcerative colitis (UC) and other GI diseases.
We expect investor focus to stay on the successful development of the candidate. Synergy Pharma currently carries a Zacks #3 Rank (Hold). Meanwhile, Ironwood Pharma carries a Zacks #1 Rank (Strong Buy).