Synergy Pharmaceuticals presents additional Phase III plecanatide data in CIC at DDW

Both plecanatide 3 mg and 6 mg doses met the primary endpoint.

The primary endpoint for both pivotal trials was the durable overall complete spontaneous bowel movement (CSBM) responder endpoint, as defined by the FDA. Both plecanatide 3 mg and 6 mg doses met the primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall CSBM responders compared to placebo during the 12-week treatment period (21.0% in 3 mg and 19.5% in 6 mg dose groups compared to 10.2% in the placebo group; p<0.001 for both doses in Study-00 and 20.1% in 3 mg and 20.0% in 6 mg dose groups compared to 12.8% in the placebo group; p=0.004 for both doses in Study-03). The most common adverse event (AE) was diarrhea (5.9% in 3 mg and 5.7% in 6 mg dose groups compared to 1.3% in the placebo group for Study-00 and 3.2% in 3 mg and 4.5% in 6 mg dose groups compared to 1.3% in the placebo group in Study-03).

“CIC presents a serious burden for patients and there is a significant need for more treatment options that are effective, well tolerated and convenient,” said lead investigator Philip B. Miner, Jr., President and Medical Director of the Oklahoma Foundation for Digestive Research. “The data presented show that plecanatide has the potential to help patients with constipation increase their frequency of bowel movements with a low rate of diarrhea. I am very encouraged by these data and the potential for plecanatide as a new treatment option for CIC.”