Axovant Sciences said its Phase 3 MINDSET clinical trial of the investigational therapy intepirdine did not meet the study’s primary goal.
In the trial, patients received 35 mg of intepirdine and were assessed at 24 weeks for any changes in cognition scores or measures of daily living, using two tests: ADAS-Cog (Alzheimer’s Disease Assessment Scale-Cognitive Subscale) and ADCS-ADL (Alzheimer’s Disease Cooperative Study-Activities of Daily Living).
Yet after 24 weeks, patients taking the oral compound showed no significant improvement over those on placebo in either score. However, one key secondary endpoint did show a significant improvement: CIBIC+ (Clinician Interview-Based Impression of Change plus caregiver interview). Intepirdine was also well-tolerated among the patients.
Unfortunately, Alzheimer’s clinical trials have a history of failure over the past 15 years and this is just one more. Axovant says it will work with researchers running the MINDSET open-label extension study to conclude the clinical trial.
Axovant is also conducting the HEADWAY trial which studies intepirdine in patients with dementia with Lewy bodies (DLB). This trial, which remains on track to deliver results by year’s end, is investigating two dose of intepirdine — 35 mg and 70 mg — in DLB patients. The U.S. Food and Drug Administration has granted intepirdine Fast Track Designation for treatment of DLB.
“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,” Dr. David Hung, CEO of Axovant, said in a press release. “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.”
Hung added: “We are grateful to the investigators, patients and caregivers who participated in this important trial and supported us in this journey. Moreover, we remain committed to advancing our pipeline, which includes our Phase 2b HEADWAY study of intepirdine, and nelotanserin, our highly selective inverse agonist of the 5-HT2A receptor in Phase 2 development, both of which are being evaluated in patients with dementia with Lewy bodies.”
Intepirdine is an agonist of the 5HT6 receptor, which is expressed in the central nervous system. It helps the brain release acetylcholine — a neurotransmitter deficient in Alzheimer’s patients that is necessary for memory, thought, alertness and judgement.
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