EnVivo Pharmaceuticals to Present Phase 2b Clinical Data of Lead Program in Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2012
Phase 2b Data for EVP-6124 Selected for Oral Presentation in AAIC Late Breaking Novel Therapeutics Session; EnVivo Also Selected to Participate in AAIC News Briefing
WATERTOWN, Mass. – June 13, 2012 – EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, today announced that the company will present a comprehensive analysis of its recently completed Phase 2b clinical trial of EVP-6124 in Alzheimer’s disease at the Alzheimer’s Association International Conference 2012 (AAIC), being held July 14-19, 2012 in Vancouver, British Columbia. The data have been selected for oral presentation as part of the conference’s “Late Breaking Novel Therapeutics” session, being held Wednesday, July 18, 2012 from 3:30 to 5 p.m. The data presentation will also be highlighted in an Alzheimer’s Association news briefing at the conference on Wednesday, July 18, 2012 from 7:30 to 8:30 a.m.
“These data mark an important step forward for EVP-6124 and the development of EnVivo’s broad pipeline of CNS therapies,” said Kees Been, president and chief executive officer of EnVivo Pharmaceuticals. “We look forward to sharing the data analysis with our colleagues and the scientific community at AAIC 2012.”
EVP-6124 is a selective alpha-7 nicotinic agonist being studied in patients with mild to moderate Alzheimer’s disease. The Phase 2b multi-center, dose ranging, placebo controlled, six-month study took place in the U.S. and Europe and was designed to determine the safety and efficacy of EVP-6124 in producing procognitive effects and improving the clinical condition of Alzheimer’s disease patients. The primary endpoints of the trial were improvement in cognition as measured by the Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-cog), a commonly used and established outcome measure, and the CDR-SB, a clinical rating scale that assesses patient function.
EnVivo Pharmaceuticals’ lead compound, EVP-6124, is a selective, potent, brain penetrant, oral alpha-7 nicotinic agonist being developed as a long-term treatment to restore and improve cognitive function with sustained effect in Alzheimer’s disease and schizophrenia. EVP-6124 offers a novel mechanism of action by enhancing synaptic transmission in the brain and acting as a co-agonist in combination with Acetylcholine (ACh) to enhance cognition.
EnVivo announced positive topline data from its double-blind, placebo-controlled Phase 2b clinical trial of EVP-6124 in schizophrenia in May 2011 and presented a comprehensive analysis of these findings in December 2011. Results demonstrated EVP-6124’s statistically significant and clinically meaningful effects on both cognition and functional symptoms, including global cognitive function, clinical function and negative symptoms. 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.