Synergy reports positive Phase III trial results of plecanatide in CIC patients

The trial evaluated the efficacy and safety of two different plecanatide treatment doses (3mg and 6mg), taken as a tablet once-a-day, in 1337 adults with CIC.

According to the preliminary analysis, both plecanatide doses met the trial’s primary endpoint and showed statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period.

The company noted that the durable overall responder endpoint is the current FDA endpoint required for US approval in CIC.

Oklahoma Foundation for Digestive Research president and medical director Philip Miner said: "Chronic constipation is a very complex and debilitating disease that often impacts patients on a daily basis.

"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."

Stool consistency was the key secondary endpoint reported with top-line analyses, while both plecanatide doses showed statistically significant improvement from baseline in Bristol Stool Form Scale (BSFS) scores compared to placebo.

Synergy chairman and CEO Gary Jacob said: "We now have successfully completed the two largest phase III 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."

In the first phase III CIC trial, conducted in North America, a total of 1,346 adult patients were randomly assigned to take 3mg or 6mg plecanatide or placebo once-a-day during the 12 week treatment period.