In the randomized, double-blind, placebo controlled Phase II trial, 1mg dose of DDP225 administered once daily for eight weeks achieved a 71% response rate compared to a 25% response rate for placebo in the prospectively defined clinical endpoint of adequate relief of irritable bowel syndrome (IBS) pain or discomfort.
This was a statistically significant benefit over placebo using an efficacy measure accepted by the FDA as the basis for approval for treatment of IBS-d. DDP225 was safe and well tolerated in this study.
Dynogen’s Phase II trial enrolled 87 women at multiple centers in the US and Canada. DDP225 is an oral noradrenaline reuptake inhibitor (NARI) and a weak 5HT3 receptor antagonist that Dynogen is developing for IBS-d.
Lee Brettman, president and CEO of Dynogen, said: “We are on track to have four Phase III-ready programs within the next 24 months, based on these data and positive results in our planned trials.”