Plecanatide safely treats patients with chronic idiopathic constipation
The second of two phase 3 clinical trials evaluating the safety and efficacy of plecanatide for the treatment of adults with chronic idiopathic constipation showed positive top-line results, the manufacturer announced.
Plecanatide (Synergy Pharmaceuticals) is a uroguanylin analogue under development for the treatment of chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome, according to a press release.
“We are thrilled with the positive results of this trial,” Gary S. Jacob, PhD, chairman and CEO of Synergy, said in a press release. “We now have successfully completed the two largest phase 3 trials ever conducted in CIC and plecanatide’s treatment effect and tolerability profile have been remarkably consistent. We look forward to filing our first NDA with plecanatide in the CIC indication and the opportunity to bring this novel treatment to market.”
According to the release, the plecanatide phase 3 CIC program, designed to support U.S. regulatory submission, consisted of two double-blind randomized controlled trials evaluating the safety and efficacy of once-a-day 3- and 6-mg plecanatide tablets. Both trials had 12-week treatment periods, 2-week pretreatment baseline periods and 2-week post-treatment periods.
The second evaluated 1,337 adult patients (78.4% women) in the U.S. who were randomly assigned to receive either dose of plecanatide or placebo. Preliminary analysis shows 20.1% of the 3-mg dose group and 20% of the 6-mg dose group were durable responders compared with 12.8% of the placebo group (both P = .004). Therefore, the primary endpoint required by the FDA for approval was met by both doses. Both doses were also found to be safe and well-tolerated, and the most common adverse event was diarrhea, occurring in 3.2% of the 3-mg group, 4.5% of the 6-mg group and 1.3% of the placebo group. Stool consistency also improved with both doses compared with placebo (both P < .001).
“Chronic constipation is a very complex and debilitating disease that often impacts patients on a daily basis,” Philip B. Miner Jr., MD, president and medical director at Oklahoma Foundation for Digestive Research, said in the release. “These individuals need treatment options that are not only effective in alleviating constipation but also provide the safety and tolerability features that are absolutely critical for daily use. I am very encouraged by these latest plecanatide data and the excellent potential it has to address the unmet needs of millions of patients suffering from this chronic GI condition.”
The company plans to present further data from both trials at upcoming scientific conferences, and plans to file its first new drug application with plecanatide for CIC in January 2016, according to the release.
Disclosures: Jacob is an employee of Synergy. Healio Gastroenterology could not confirm Miner’s relevant financial disclosures at the time of publication.