DYNOGEN REPORTS POSITIVE RESULTS FROM IBS STUDY

Dynogen Pharmaceuticals has reported positive results from its randomized, double-blind, placebo-controlled, parallel-group, Phase II trial of DDP733 in patients with irritable bowel syndrome (IBS) with constipation. DDP733 achieved an overall clinical response rate of 54 percent in patients receiving a dose of 1.4 mg three times a day compared with a 15 percent clinical response rate for patients receiving placebo. This was a statistically significant difference in the clinical endpoint, which has been accepted by the FDA as a registration endpoint for this indication.

The trial enrolled 91 men and women with IBS as determined by the Rome II criteria at multiple centers in Canada. The clinical response rate was assessed using the Overall Subject Global Assessment of relief of IBS, an accepted measure for efficacy in IBS clinical trials. Additionally, a pharmacodynamic assessment of gastrointestinal transit time was included in the study, but the assay did not perform reliably and no conclusions could be drawn.

DDP733 was well tolerated with no unexpected drug-related adverse events. Drug-related adverse events were mainly mild to moderate and transient, and required no intervention.

DDP733 is an oral, partial agonist of the serotonin type 3 receptor. Serotonin is a neurotransmitter that is known to be involved in the control of the gastrointestinal system. Preclinical studies of DDP733 established the compound's prokinetic properties. Dynogen's preclinical studies have also shown that DDP733 is minimally absorbed by the cells lining the gastrointestinal tract and, as a result, more of the product candidate remains available at the desired local site of action.

Dynogen is also studying DDP733 in a Phase Ib clinical trial as a treatment for nocturnal gastroesophageal reflux disease, and expects to complete enrollment in that trial in the first half of 2007.