EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

EnVivo Pharmaceuticals today announced the initiation and dosing of patients in a Phase 2b study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with schizophrenia. EnVivo is conducting the multi-center, dose ranging, placebo controlled, three-month study in the U.S. and Europe.

The study is designed to determine the safety and efficacy of EVP-6124 in producing procognitive effects and improving executive function in schizophrenic patients who typically exhibit significant cognitive symptoms that impair normal functioning. This study will determine if EVP-6124 can produce both cognitive and clinical improvement in schizophrenic patients.

"Patients with schizophrenia have a well documented deficit in cognitive function," said Kees Been, EnVivo president and CEO. "The cognitive impairment in schizophrenia is not effectively treated with present antipsychotic medications and there is growing consensus that alpha-7 nicotinic agonists can potentially improve the cognitive function in patients. The potential upside for patients is considerable and we look forward to completing our study by the end of this year."

EVP-6124 is a selective agonist for the alpha-7 subtype of the nicotinic acetylcholine receptor and is being developed by EnVivo for potential cognitive enhancement in both schizophrenia and Alzheimer's patients. It has been shown to have excellent CNS penetration, oral bioavailability, pharmacokinetics and metabolic profile. A majority of patients with schizophrenia have substantial residual clinical deficits including cognitive dysfunction in spite of therapy with either typical or atypical antipsychotic drugs. These deficits affect thinking and prevent many patients from employment and leading productive lives.

A previous study with EVP-6124 in chronic schizophrenia patients on stable long term antipsychotic medications demonstrated that it was well tolerated and produced significant effects on a variety of electrophysiologic measures of brain function assessing sensory processing and working memory formation. Patients with schizophrenia have abnormalities in a number of evoked responses (ERPs) that measure brain function including the p50, N100, Mis-Match Negativity, and p300 responses. EVP-6124 had normalizing effects on all of these abnormal responses including the Mis-Match Negativity Response which correlates significantly with the level of clinical function in schizophrenia patients.

The Phase 2b study will enroll schizophrenia patients in four separate countries (US and Europe) and randomize patients to two separate doses of EVP-6124 or placebo over three months. The primary measures of efficacy will be computerized cognitive function and secondary measures will include other cognitive and clinical measures. EnVivo expects the study to be fully enrolled in 2010 with data available in early 2011. EVP-6124 also will be tested in patients with Alzheimer's disease in a separate Phase 2b study expected to start in early 2010.