Synergy reports positive results from Phase IIb/III chronic idiopathic constipation trial

3rd January 2013 (Last Updated January 3rd, 2013 18:30)

Synergy Pharmaceuticals has reported positive results from Phase IIb/III trial of plecanatide in patients with chronic idiopathic constipation (CIC).

Synergy Pharmaceuticals has reported positive results from its Phase IIb/III trial of plecanatide in patients with chronic idiopathic constipation (CIC).

The company's investigational oral drug was well tolerated, and has met the primary and key secondary endpoints of the double-blind, placebo-controlled study.

Synergy Pharmaceuticals president and CEO Dr Gary Jacob said the company will present the full results of this clinical study, which confirmed the efficacy and safety of plecanatide.

"We pioneered the study of analogs of the human hormone uroguanylin to treat gastrointestinal disorders in an effort to identify an agent that would normalize bowel movements with minimal diarrhea," Jacob said.

"The company's investigational oral drug was well tolerated, and has met the primary and key secondary endpoints of the double-blind, placebo-controlled study."

"Based on the results of this trial, we are convinced that plecanatide has the potential to be a safe, effective and much-needed new treatment for millions of patients who are living with chronic constipation."

The randomised, repeat-dose study, which lasted for 12 weeks, included 951 CIC patients and assessed 0.3mg, 1.0mg and 3.0mg doses of plecanatide in addition to a placebo arm.

The dose-ranging study was designed to assess the ability of plecanatide in increasing the number of complete spontaneous bowel movements (CSBM) and showing an impact on other parameters including stool consistency, straining and time to first bowel movement in CIC patients.

The study data highlighted the improved efficacy of the drug at increasing dose levels, particularly the 3mg dose, which demonstrated a 19% overall responder rate against a 10.7% rate for placebo.

The 3mg dose demonstrated a mean increase in CSBMs over the 12-week treatment period of 2.13.

Synergy also announced statistically significant improvements in key secondary endpoints.