EnVivo has completed 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, said the company.
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.
This phase Ib/IIa safety and biomarker study was conducted 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.
Kees Been, CEO of EnVivo, said: EVP-6124 appears to be safe and was well tolerated over a month of dosing. 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.