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Plecanatide improves IBS-C symptoms in phase 3 trial
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Plecanatide improved abdominal pain and constipation in patients with constipation-predominant irritable bowel syndrome in the first of two phase 3 clinical trials, the manufacturer announced.
Plecanatide (Synergy Pharmaceuticals) is an investigational oral peptide composed of 16 amino acids that is designed to replicate the function of the natural human GI peptide uroguanylin, which targets GC-C receptors mainly in the proximal small intestine, thereby stimulating fluid secretion and promoting stool consistency, according to a press release.
“These data reinforce our strong belief that plecanatide may represent an important new treatment option for the millions of patients currently suffering from IBS-C,” Gary S. Jacob, PhD, chairman and CEO of Synergy Pharmaceuticals Inc., said in the press release. “We look forward to the results of our second phase 3 IBS-C trial with plecanatide later this month.”
The plecanatide phase 3 IBS-C program includes two randomized, double blind, placebo-controlled trials assessing the drug’s safety and efficacy at two doses. In the first of these trials, researchers randomly assigned 1,135 patients with IBS-C (71.8% women) to receive either 3 mg (n = 377) or 6 mg oral plecanatide (n = 379) or placebo (n = 379) once daily for 12 weeks following a 2-week pre-treatment baseline period.
The proportion of overall responders served as the primary endpoint, defined by the FDA as at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement from baseline, in the same week, for at least half of the 12 treatment weeks.
Preliminary analysis showed 21.5% of the 3-mg group and 24% of the 6-mg group vs. 14.2% of the placebo group were overall responders (P = .009 and P < .001). Diarrhea was the most common adverse event, occurring in 3.2% of the 3-mg group, 3.7% of the 6-mg group and 1.3% of the placebo group. Four patients (0.4%) experienced serious adverse events and these occurred in comparable proportions across groups. Overall, 1.9% of the 3-mg group, 1.8% of the 6-mg group vs. none in the placebo group withdrew from treatment due to an adverse event, and 0.8%, 1.6% and 0, respectively, withdrew due to diarrhea.
The FDA is currently reviewing plecanatide for the treatment of chronic idiopathic constipation, with a Prescription Drug User Fee Act target action date of January 29, 2017, and pending approval in this indication, Synergy expects to file a New Drug Application Supplement for IBS-C in the first quarter of the new year.
Disclosures: Jacob is employed by Synergy Pharmaceuticals.