VIENNA, July 15 /PRNewswire/ -- EnVivo Pharmaceuticals today announced the successful completion of a phase Ib/IIa trial in Alzheimer's disease patients with its nicotinic alpha-7 agonist EVP-6124. Subjects receiving EVP-6124 experienced improvement in cognition and EVP-6124 showed good tolerability and safety.
The announcement came at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease (ICAD) in Vienna, Austria where EnVivo presented its findings. EVP-6124 is EnVivo's novel alpha-7 nicotinic acetylcholine receptor agonist currently in development for cognitive dysfunction associated with Alzheimer's disease and schizophrenia.
"EVP-6124 appears to be safe and was well tolerated over a month of dosing," commented Kees Been, CEO of EnVivo. "Most excitingly, the cognition improvement was observed on top of the effect of acetylcholinesterase inhibitors the patients were already taking. This is a strong indicator of a biologic and potentially useful clinical effect."
In this Phase Ib/IIa safety and biomarker study in patients with mild to moderate Alzheimer's disease already taking chronic acetylcholinesterase inhibitor (AChEI) therapy (donepezil or rivastigmine), three separate doses of EVP-6124 or a placebo dose were administered to a total of 48 subjects for 28 days. Safety and tolerability were determined by adverse events, clinical assessments, and laboratory studies. Cognition in AD patients was measured using the computerized CogState battery system and a group of traditional 'paper and pencil' cognition tests.
Minimal treatment-emergent adverse effects were observed during the trial and there were no serious adverse events. Improvement in a number of cognition measures in EVP-6124 treated patients were observed compared to placebo treated patients. These included measures of attention, verbal and language fluency, and executive function. Four of the eight cognition measures showed statistically significant dose-dependent effects and two others showed a trend towards improvement.
Based on the success of the trial, EnVivo plans to proceed to larger and longer Phase 2 studies to better define both the pro-cognitive effects of EVP-6124 as well as to measure its potential clinical benefit.
About EnVivo Pharmaceuticals
EnVivo Pharmaceuticals, located in Watertown, Mass., is a biopharmaceutical company dedicated to discovering and developing small molecule therapeutics for disorders of the central nervous system, with a current focus on Alzheimer's disease, Cognitive Disorders and Schizophrenia. The company's lead product is an alpha-7 nicotinic acetylcholine receptor agonist and has been tested in Phase IIa clinical trials for cognition disorders in Alzheimer's disease and Schizophrenia. The company's other programs include an epigenetics program based on Histone Deacetylase inhibition (HDACi) with EVP-0334 as the lead molecule for cognition in Alzheimer's disease which is in Phase I studies, and several preclinical programs such as a Gamma Secretase Modulator (for Alzheimer's disease) and a PDE10 inhibitor program (for schizophrenia). For more information about EnVivo, visit www.envivopharma.com.
|SOURCE EnVivo Pharmaceuticals|
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