EnVivo presents positive EVP-6124 Phase 2b trial data on schizophrenia at 50th ACNP meeting

Dec 5 2011

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it is presenting the comprehensive analysis of a recently completed Phase 2b clinical trial of EVP-6124, a novel, orally bioavailable nicotinic alpha-7 agonist, in schizophrenia at the American College of Neuropsychopharmacology 50^th Anniversary Annual Meeting. Data were discussed as part of the meeting's "Hot Topics" invited panel session on Sunday, December 4 and will be presented in two posters today, Monday, December 5.

Results presented at ACNP show EVP-6124's statistically significant and clinically meaningful effects on both cognition and functional symptoms, including global cognitive function, the Phase 2b trial's pre-specified primary endpoint, as measured by the CogState computerized battery. Building upon these findings, EnVivo is planning to advance the program into Phase 3 clinical trials in 2012 with a primary focus on improving cognition in schizophrenia patients.

"Almost all schizophrenia patients suffer from debilitating functional impairment, due in large part to cognitive or negative symptoms, for which there are no currently approved treatments," said Herbert Y. Meltzer, M.D., Ph.D., professor in psychiatry and behavioral sciences at the Northwestern University Feinberg School of Medicine and an investigator in the Phase 2b trial. "As a clinician, I know that patients and their families are suffering due to the current lack of effective and tolerable treatments for these two key components of the syndrome. These encouraging data further support EVP-6124's potential as a novel approach that could improve cognitive function and decrease the negative symptoms of schizophrenia, thereby having a dramatic impact on the way schizophrenia is treated and on patients' quality of life."

Dana Hilt, M.D., senior vice president, clinical development and chief medical officer of EnVivo, presented the Phase 2b data as part of the ACNP "Hot Topics" session along with Dr. Meltzer. The comprehensive findings show that:

• EVP-6124 demonstrated a statistically significant effect on global cognitive function, the trial's pre-specified primary endpoint as measured by the CogState battery, for all EVP-6124 treated patients versus placebo>
• Significant effects in the secondary endpoint of clinical function also were seen with EVP-6124 treatment as measured by the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Rating. The 1.0 mg dose group showed a statistically significant improvement>
• Improvement was also seen in the secondary endpoint assessing negative symptoms of schizophrenia as measured by the Positive and Negative Symptoms Scale (PANSS). The 1.0 mg dose group showed a statistically significant decrease in negative symptoms>
• 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 four percent), 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," said Dr. Hilt. "We are encouraged by the results across both dose arms and the broad range of primary and secondary endpoints. We are now working with leading clinicians and researchers to finalize the design of our Phase 3 trials to maximize these learnings and most efficiently and effectively evaluate EVP-6124 in schizophrenia patients who have significant unmet medical needs."

"These findings represent a significant advance in the development of a novel, safe and effective treatment for schizophrenia," said Kees Been, president and chief executive officer of EnVivo Pharmaceuticals. "This clinical 'proof of concept' in humans is an important milestone for any drug candidate and was a pivotal event for EnVivo. We expect to move into Phase 3 development with a focus on the cognitive symptoms of schizophrenia next year. We also look forward to sharing updates from our current ongoing Phase 2b clinical trial of EVP-6124 in patients with Alzheimer's disease in the first half of 2012."

Today, EnVivo and Dr. Meltzer also will present two posters at ACNP. The first will highlight the Phase 2b data previously discussed during the "Hot Topics" session. The second will outline findings in a preclinical pharmacology model that show that EVP-6124 acts as a co-agonist and sensitizes the alpha-7 receptor, enhancing cognition and memory and also increases the release of dopamine, acetylcholine and glutamate.