EnVivo Pharmaceuticals announced the analysis of a completed Phase 2b clinical trial of EVP-6124, a novel, orally bioavailable nicotinic alpha-7 agonist, in schizophrenia.
The trial evaluated the safety and efficacy of two doses of EVP-6124 (0.3 mg and 1.0 mg per day) versus placebo in chronic schizophrenia patients on stable second-generation antipsychotic drugs (except clozapine). Each patient was treated for three months and a total of 319 patients were enrolled in the United States, Russia, Ukraine, and Serbia. The trial’s primary endpoint was overall cognition as measured by the CogState overall cognitive index and important secondary endpoints included cognition as assessed by the MCCB battery, clinical function (as measured by the SCoRS) and positive and negative symptoms (measured by PANSS). Safety and tolerability were also assessed.
EVP-6124 was well tolerated over three months of dosing, with an excellent safety and tolerability profile—the most commonly reported adverse events were headache, nausea and nosopharyngitis (all less than 4%), there were no drug-related serious adverse events and more adverse events were reported in the placebo group than in the EVP-6124 treated groups.
“Our Phase 2b trial was an important clinical success as we saw statistically significant improvements in all pre-specified endpoints including cognitive function and negative symptoms and have learned more about our potential optimal dose,” says Dana Hilt, MD, senior vice president, clinical development and chief medical officer of EnVivo. “We are now working with leading clinicians and researchers to finalize the design of our Phase 3 trials to maximize these learnings and evaluate EVP-6124 in schizophrenia patients who have significant unmet medical needs.”
EnVivo expects to move into Phase 3 development with a focus on the cognitive symptoms of schizophrenia next year.
Release Date: Dec. 5, 2011
Source: EnVivo Pharmaceuticals Inc.