Biotech Values

[iandy]

SGYP - old news but good news (from Nov 2014)
Synergy Pharmaceuticals Announces Positive Results of SP-333 Phase 2 Trial in Patients with Opioid-Induced Constipation

NEW YORK-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced positive top-line results from a phase 2 trial assessing safety, efficacy and dose-response of three different once-daily oral SP-333 tablets (1.0, 3.0 and 6.0 mg) compared with placebo in 289 patients with opioid-induced constipation (OIC). Preliminary analysis of the data indicates SP-333 met the study’s primary endpoint and demonstrated statistically significant improvement in mean change from baseline in the number of spontaneous bowel movements (SBMs) during Week 4 of the treatment period. SP-333 was safe and well tolerated at all doses.

“SP-333 is the first and only GC-C agonist to demonstrate efficacy in treating OIC patients,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc. “Synergy now has a clinically validated platform technology consisting of two very unique GC-C agonists – plecanatide and SP-333 – both analogs of the natural GC-C agonist, uroguanylin, with proven efficacy and excellent tolerability for treating a variety of gastrointestinal conditions. We look forward to evaluating the full dataset over the coming weeks and plan to present additional results at an appropriate scientific meeting.”

Trial Results

SP-333 3.0 and 6.0 mg doses demonstrated statistically significant improvement in mean change from baseline in the number of SBMs during Week 4 of the treatment period (increase from baseline of 3.2, 3.4 and 1.8 for 3.0, 6.0 mg and placebo dose groups, respectively; p= 0.009 and 0.005 for the comparison of 3.0 and 6.0 mg SP-333 with placebo). SP-333 treatment effect was immediate and sustained throughout the four weeks. Additionally, SP-333 3.0 and 6.0 mg dose groups showed statistically significant improvement in a key secondary endpoint analysis of complete spontaneous bowel movement (CSBM) frequency (increase from baseline of 2.54, 2.39 and 1.36 for 3.0, 6.0 mg and placebo dose groups, respectively; p= 0.003 and 0.01 for the comparison of 3.0 and 6.0 mg SP-333 with placebo).

All doses were safe and well tolerated with only four serious adverse events reported (2 for placebo, 1 for the 3.0 mg and 1 for the 6.0 mg dose groups). Diarrhea incidence was low and was the most commonly reported adverse event (4.0%, 5.4%, 9.7% and 0% for 1.0, 3.0, 6.0 mg and placebo dose groups, respectively). Only two patients withdrew from the study due to diarrhea (both in the 6.0 mg dose group).

http://ir.synergypharma.com/press-releases/detail/1734/synergy-pharmaceuticals-announces-positive-results-of-sp-333-phase-2-trial-in-patients-with-opioid-induced-constipation