Synergy's SP-333 Phase 2 Trial Shows Positive Results

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) Wednesday said it recorded positive top-line results from its phase 2 trial, assessing safety, efficacy and dose-effects of its agonist SP-333 in patients with opioid-induced constipation or OIC. The company, referring to preliminary data analysis, said that results met the trial's primary endpoint.

Synergy further said SP-333 treatment effect was immediate and sustained during the 4-week trial period and that SP-333 was safe and well tolerated at all doses.

The randomized, double-blind trial involved comparing the effect of three different SP-333 doses of 1.0 mg, 3.0 mg and 6.0 mg with placebo, in patients with constipation, taking opioid analgesics for at least three months, the company said.

According to Synergy's results, 3.0 mg and 6.0 mg doses of SP-333 showed improvement in mean change from baseline, in number of spontaneous bowel movements during fourth week.

The 3.0 mg and 6.0 mg doses showed increase of 3.2 and 3.4 units respectively, while placebo showed a rise of 1.8 units.