6:06AM Furiex Pharmaceuticals announces positive top-line results of two pivotal Phase III clinical trials of eluxadoline in patients with IBS-d; studies meet FDA and EMA primary endpoints (FURX) 45.97 :
Co announced top-line results indicating the co's two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d) met both the FDA and the European Medicines Agency (EMA) formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain. These endpoints are aligned with both the current FDA guidance and the 2013 EMA draft guidance for clinical trial evaluation of new medicines for irritable bowel syndrome.
"In just under four years, working closely with regulatory authorities, the team has completed nine Phase I studies, a Phase II dose-ranging trial in approximately 800 patients, and these two large Phase III trials. Additionally, we have completed all toxicology studies and believe we are on schedule, including chemistry and manufacturing work, for an NDA submission by the end of the second quarter of 2014."
Key Findings from Study 3002 (intention-to-treat analysis): Patients receiving eluxadoline demonstrated statistically significantly higher responder rates for the following composite primary endpoints:
For the FDA composite endpoint (response over weeks 1-12), the responder rates were 29.5% for eluxadoline 100 mg, 28.9% for eluxadoline 75 mg and 16.2% for placebo (p <0.001 both doses); and
For the EMA composite endpoint (response over weeks 1-26), the responder rates were 32.6% for 100 mg, 30.4% for 75 mg and 20.2% for placebo (p =0.001 both doses).
With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher rates of stool consistency response over weeks 1-12, namely 100 mg=35.5%, 75 mg=37.0% and placebo=20.9% (p <0.001 both doses), and numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=50.9% vs. placebo=45.3%, p =0.12).
Key Findings from Study 3001 (intention-to-treat analysis):
Patients receiving eluxadoline demonstrated statistically significantly higher response rates for the following primary composite endpoints: For the FDA composite endpoint (response over weeks 1-12), the responder rates were 25.1% for eluxadoline 100 mg (p =0.004), 23.9% for eluxadoline 75 mg (p =0.014) and 17.1% for placebo; and
For the EMA composite endpoint (response over weeks 1-26), the responder rates were 29.3% for 100 mg (p <0.001), 23.4% for 75 mg (p =0.11) and 19.0% for placebo.
With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher response rates of stool consistency over weeks 1-12, namely 100 mg=34.3%, 75 mg=30.0% and placebo=22.0% (p <0.009 both doses) and, numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=43.2% vs. placebo=39.6%, p =0.28).
Furiex will conduct a live conference call and webcast Tuesday, February 4, 2014 at 8:30 a.m. ET to discuss the top-line results.
