Additional data from EnVivo’s EVP-6124 Phase 2b trial on AD presented at CTAD meeting

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, today presented pharmacokinetic and pharmacodynamic data along with the previously reported statistically significant clinical results from its Phase 2b clinical trial of EVP-6124, a novel alpha-7 agonist, in patients with Alzheimer's disease. The data were highlighted in an oral presentation at the 5th Clinical Trials on Alzheimer's Disease (CTAD) Meeting, being held in Monte Carlo, Monaco. New data presented today demonstrate a significant relationships Disease Assessment Scale-Cognitive subscale-13 (ADAS-Cog-13). Positive results from this Phase 2b trial were also presented in July 2012 during the Late Breaking Novel Therapeutics Session at the Alzheimer's Association International Conference (AAIC).

"The additional data from our Phase 2b trial presented today add to the positive results announced in July and continue to build the foundation for EVP-6124 as a driver of pro-cognitive effect and enhanced function in patients with Alzheimer's disease. This is particularly promising, given the lack of effective therapies and novel treatment options in development for this devastating disease," said Kees Been, president and chief executive officer of EnVivo Pharmaceuticals. "We are planning to advance EVP-6124 into a Phase 3 clinical trial in schizophrenia this fall and another Phase 3 trial program in Alzheimer's disease in 2013. This continued progress positions EVP-6124 for potential patient impact and benefit and moves us toward our goal of becoming a fully integrated biotechnology company."

The six-month, double-blind, placebo-controlled study enrolled 409 patients and evaluated three doses of EVP-6124 taken once per day - 0.3 mg, 1.0 mg and 2.0 mg - against placebo. Initial results demonstrated that the 2.0 mg dose of EVP-6124:

  • Met both of the trial's primary endpoints, with statistically significant positive effects on cognition>
  • Showed statistically significant results across several secondary endpoints of other cognitive and clinical measures; and,
  • Was generally safe and well-tolerated over the six-month dosing period for the trial.

"The addition of the pharmacokinetic and pharmacodynamic data from the Phase 2b trial demonstrate an important correlation between improved cognition and plasma levels of EVP-6124," said Dana Hilt, M.D., senior vice president, clinical development and chief medical officer of EnVivo. "We look forward to advancing EVP-6124 into Phase 3 studies, as there remains a significant need for treatment options that enhance cognition and function with an improved safety profile over currently available therapies."

Source:

EnVivo Pharmaceuticals

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