Axovant's Phase 3 Intepirdine Trial In Alzheimer's Disease Fails To Meet Goals

(RTTNews) - Axovant Sciences Ltd. (AXON) announced announced Tuesday negative topline results of Intepirdine Phase 3 MINDSET trial in Alzheimer's Disease.

In pre-market activity, Axovant shares were losing 70.7 percent to $7.10.

The company noted that the Phase 3 MINDSET clinical trial of its investigational drug intepirdine in patients with mild to moderate Alzheimer's disease or AD who were receiving background donepezil therapy did not meet its co-primary efficacy endpoints.

The global, randomized, double-blind, placebo-controlled Phase 3 MINDSET trial evaluated the efficacy, safety and tolerability of intepirdine in patients with mild to moderate AD on donepezil therapy over 24 weeks.

At 24 weeks, patients treated with 35 mg of intepirdine did not experience improvement in cognition or in measures of activities of daily living, compared to patients treated with placebo. In the study, intepirdine was generally well tolerated.

After 24 weeks of treatment, change from baseline in cognition was non-significantly improved in the intepirdine arm versus the placebo arm. In addition, there was essentially no difference between the intepirdine and placebo arms in change from baseline in activities of daily living.

According to the firm, the only endpoint in which any significant improvement was seen in the intepirdine arm versus the placebo arm was in the first key secondary endpoint, the Clinician Interview-Based Impression of Change plus caregiver interview, or CIBIC+.

The company said it will work with investigators to conclude the MINDSET open-label extension study.

David Hung, M.D., chief executive officer of Axovant, said, "While we are deeply disappointed by these trial results, we also are saddened for the millions of patients and families impacted by Alzheimer's disease. However, we believe that the fight against Alzheimer's and other important areas of unmet need in neurology is too important to be derailed by this setback."

The HEADWAY trial studying intepirdine in patients with dementia with Lewy bodies remains on track to report topline results at the end of 2017.