IW-3718: Phase IIa data
Top-line data from a double-blind, U.S. Phase IIa trial in 93 patients with refractory GERD who were taking a proton pump inhibitor (PPI) and continued to experience frequent GERD symptoms showed that twice-daily 1,000 mg oral IW-3718 led to a greater reduction in average heartburn severity as measured by a 10-point scale from baseline to week 4 vs. placebo (1.7 vs. 1.2 points). Additionally, IW-3718 increased the percentage of heartburn-free days from baseline to week 4 (30.3% vs. 24.7%) and led to a greater response rate (45.7% vs. 27.7%) vs. placebo. Responders were defined as patients who reported scores of 1 (completely relieved) or 2 (considerably relieved) points on a 7-point scale for >=2 of 4 weeks in the treatment period, or who reported scores of 1, 2 or 3 (somewhat relieved) points for all 4 weeks. Ironwood said the trial was not powered to show significance of a particular endpoint. ...