Dynogen presents positive results from Phase IIa IBS trial

The randomized, double-blind, placebo controlled, parallel group study established clinical proof-of-concept and demonstrated a statistically significant improvement over placebo in the endpoint of overall subject global assessment of irritable bowel syndrome (IBS). The drug candidate was also well-tolerated.

In the Phase IIa IBS-c study, 91 patients were randomized in a double-blind fashion to one of five treatment groups (placebo, 0.2, 0.5, 0.8 or 1.4mg) and study medication was administered three times per day for 28 days. Patients used a diary to record their overall global assessment of relief of IBS, as well as data related to specific IBS symptoms, study medication, rescue medication use, and adverse events.

DDP733 achieved a statistically significant benefit in the protocol defined clinical endpoint of overall relief of IBS as measured by OSGA with 54% of subjects in the 1.4mg dose group responding to treatment compared to 15% of subjects in the placebo group (p=0.039). No other treatment groups were statistically different from placebo. Consistent improvements in the individually recorded symptoms supported overall efficacy. DDP733 was safe and well-tolerated in this study.

Suhail Nurbhai, vice president of clinical development at Dynogen, said: “We believe the strong clinical efficacy and good safety profile will clearly differentiate DDP733 from other drugs for IBS-c.”