Axovant Phase 3 Alzheimer's study misses co-primary endpoints
Axovant Sciences announced that the Phase 3 Mindset clinical trial of its investigational drug intepirdine in patients with mild to moderate Alzheimer's disease who were receiving background donepezil therapy did not meet its co-primary efficacy endpoints. At 24 weeks, patients treated with 35 mg of intepirdine did not experience improvement in cognition or in measures of activities of daily living as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale and by the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale, respectively, compared to patients treated with placebo. In the study, intepirdine was generally well tolerated, the company added. 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. Of the endpoints analyzed to date, 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-plus. Axovant said, "The Company will work with investigators to conclude the MINDSET open-label extension study. " David Hung, CEO of Axovant, added, "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.... We remain committed to advancing our pipeline." Axovant shares remain halted. They closed yesterday down 6c to $22.59.