Synergy Pharmaceutical's constipation drug garners positive results

Synergy Pharmaceuticals’ drug for chronic idiopathic constipation (CIC) has garnered very positive results in a phase 3 clinical trial, the company reported this week.

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If approved by FDA, plecanatide would be the first drug approved for CIC using the more stringent regulatory requirement for durability by FDA. Only 2 other drugs – Amitiza from Sucampo Pharmaceuticals and Takeda Pharmaceutical Co. Ltd. and Linzess from Allergan Plc and Ironwood Pharmaceutical – are on the market for CIC.

Synergy plans to file its first new drug application (NDA) for plecanatide in the fourth quarter of this year.

Preliminary analysis of the data in a clinical trial of 1,346 adult patients found that both plecanatide 3.0-mg and 6.0-mg doses “demonstrated 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. Notably, plecanatide was safe and well tolerated at both doses.

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The most common adverse event was diarrhea, which occurred in 5.9% of patients in 3.0 mg and 5.5% of patients in 6.0-mg dose groups, compared to 1.3% of placebo-treated patients.

“We are very pleased with these results and how well they confirm earlier plecanatide data observed in the phase 2b/3 trial,” said Gary S. Jacob, PhD, chairman and CEO of Synergy. “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. We look forward to the results of our second pivotal trial in the coming weeks.”

Both the 3.0-mg and 6.0-mg plecanatide doses also showed significant improvement on Bristol Stool Form Scale (BSFS) scores on stool consistency compared to placebo.

Fifteen patients in the trial (1.1%) experienced serious adverse events, but there was no imbalance across treatment groups in either incidences or individual serious adverse events. Overall, the rates of withdrawal from treatment because of an adverse event were low (5.1% in 3.0 mg and 5.0% in 6.0-mg dose groups compared to 1.3% in placebo) and discontinuations due to diarrhea were infrequent (2.7% in 3.0 mg and 2.4% in 6.0-mg dose groups compared to 0.4% in placebo).