AV-101 Phase 2 Study for Adjunctive Treatment of MDD

We are currently preparing to launch a Phase 2 clinical study of AV-101 for the adjunctive treatment of MDD in patients with inadequate response to standard FDA-approved antidepressants. We anticipate the launch of this multi-center, multi-dose, double-blind, placebo-controlled Phase 2 efficacy and safety study, which is expected to enroll approximately 180 patients, in the first half of 2017. Topline clinical results from this study are expected by the end of 2018. The Principal Investigator of the study will be Dr. Maurizio Fava of Harvard Medical School. Dr. Fava was the co-Principal Investigator with Dr. A. John Rush of the largest clinical trial ever conducted in depression, STAR*D, whose findings were published in journals such the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA).

We are working in conjunction with PPD, a leading, full-service global CRO and the academic CRO within the Psychiatry Department of Massachusetts General Hospital (MGH) to conduct this study.