Epix Pharmaceuticals reported that top-line results from its Phase III trial of PRX-00023, a long-acting 5-HT1A agonist, show that PRX-00023 did not achieve a statistically significant improvement over placebo for the primary endpoint.
The primary efficacy endpoint was change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) compared to placebo. There was a trend in favor of patients treated with PRX-00023 in the HAM-A assessments. However, the outcome was potentially impacted by a higher than expected response in the placebo-treated patients.
The data from this trial did show a statistically significant improvement from baseline in the Montgomery Asberg Depression Rating Scale (MADRS), compared to placebo. The MADRS, which measures symptoms of depression, was a secondary endpoint in this trial.
“We are disappointed that treatment with PRX-00023 did not induce a statistically significant change in the HAM-A in patients with anxiety; however, we are encouraged by the MADRS data and will further analyze these results to better understand the potential benefits of PRX-00023 in patients with depression,” says Michael G. Kauffman, M.D., Ph.D., CEO.
“Based on these top-line results, we plan to refocus our efforts away from anxiety to evaluate the benefit in depression more closely and assess opportunities for initiating a Phase III clinical trial in depression sooner than originally planned.”