Synergy Pharmaceuticals announced Wednesday that the first of two its pivotal Phase 3 trials on the safety and efficacy of two treatment doses of plecanatide have yielded positive top-line results.
The trial involved 1,346 adults diagnosed with chronic idiopathic constipation. According to preliminary analysis, plecanatide in 3mg and 6mg doses achieved the trial's primary endpoint, demonstrating statistical significance in a portion of the intention-to-treat population compared to those on placebo during a 12-week period.
The said endpoint is the current one required by the U.S. Food and Drug Administration for approval in chronic idiopathic constipation. Plecanatide is the first drug to be approved for the condition utilizing highly stringent regulatory standards for durability in response.
Researchers noted that plecanatide was well tolerated and safe at both doses, with the most common adverse effect being diarrhea. About 5.9 percent of patients given 3mg doses of plecanatide and 5.5 percent of administered 6mg doses experienced the side effect, as well as 1.3 percent of those on placebo. No other relevant abnormalities were reported during serum chemistries and urinalyses as well as when vital signs or ECG measurements were taken.
"These results strengthen our belief that plecanatide has the potential to not only effectively treat constipation but with a durability and tolerability profile that is ideal for chronic use," said Gary S. Jacob, Ph.D., CEO and Chairman of Synergy.
Stool consistency was listed as a secondary endpoint for the trial, with scores from the Bristol Stool Form Scale used to rate results in the treatment and placebo groups. Those on plecanatide started showing improvements starting Week 1, with positive results stretching into Week 12.
Synergy is planning to announce the results of the second stage of its Phase 3 trial on plecanatide and chronic idiopathic constipation during the first half of the third quarter of the year. By the 2015's fourth quarter, the company is hoping to be ready with filing its first new drug application for plecanatide as treatment for chronic idiopathic constipation. The first stage of the clinical trial was carried out in North America with 453 patients given 3mg doses of plecanatide, 441 told to take 6mg doses of the drug and 452 assigned to the placebo group.
Plecanatide is an uroguanylin analogue. Uroguanylin is a gastrointestinal peptide that naturally occurs in the small intestines of people and has a hand in normalizing gastrointestinal activity. Plecanatide has been designed to mimic the functions of uroguanylin, regulating fluid movement to promote normal digestion and address constipation.
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