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news.EnVivo Pharmaceuticals has presented pharmacokinetic and pharmacodynamic data along with the previously reported clinical results from its phase 2b clinical trial of EVP-6124, a new alpha-7 agonist, in Alzheimer's patients at the 5th Clinical Trials on Alzheimer's Disease (CTAD) Meeting, held in Monte Carlo, Monaco.
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The data reveales the relationship (p=0.003) between EVP-6124 plasma concentrations and the probability of cognitive improvement measured by the Alzheimer’s Disease Assessment Scale-Cognitive subscale-13.
EnVivo Pharmaceuticals president and chief executive officer Kees Been said, "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.”
EnVivo clinical development senior vice president and chief medical officer Dana Hilt said
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.
"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," Hilt added.
409 patients were enrolled in the six-month, double-blind, placebo-controlled study, which aimed to evaluate three doses of EVP-6124 taken once per day against placebo.
The results from the study has shown that the EVP-6124 2.0 mg had positive effects on cognition (p=0.0189) and clinical function (p=0.0253) along with positive results for other secondary endpoints of the study.
The study also showed no signs of side effects from the EVP-6124 administration in the six-month trial.