EPIX Pharmaceuticals (EPIX) Announces Top-Line Results From Phase 3 Trial Of PRX-00023 In Generalized Anxiety Disorder; Drug Fails Trial
LEXINGTON, Mass.--Sept. 21, 2006--EPIX Pharmaceuticals, Inc. today announced that the top-line results from its Phase 3 trial of PRX-00023, a novel long-acting 5-HT1A agonist, show that overall 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. EPIX is continuing to analyze the data and will use these insights to guide its strategic planning process for the development of PRX-00023.
"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," said Michael G. Kauffman, M.D., Ph.D., chief executive officer, EPIX Pharmaceuticals. "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 2 clinical trial in depression sooner than originally planned."
A preliminary review has indicated that PRX-00023 was well tolerated and there was a low rate of discontinuation in this study due to adverse events. Side effects, including impact on sexual function and sleep, in patients receiving PRX-00023, were similar to placebo.
What is 5-HT? What is a 5-HT agonist? What's an agonist? How does this failed drug work and why did it fail?
Let's work through this. 5-HT is short for 5-hydroxytryptamine commonly called serotonin. It was identified by accident, when blood was allowed to clot a "tonic" substance was released that caused blood vessel constriction. Serotonin plays a role several diseases. The receptor for serotonin is 5-HT1a (for this drug) is located in the hippocampus of the brain and acts as a neurotransmitter.
An agonist binds to a particular receptor and activates it. This drug binds to the serotonin receptor and is supposed to block the cell signaling that leads to depression symptoms. It failed because the patients did not show a significant difference between the drug and placebo. It's interesting that two tests were used and it passed one.
These compounds are used as antidepressants, anxiolytics, and in the treatment of migraine.
Shares of EPIX plunged today 18% to $4.32
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