NEW HAVEN, Conn.—Biohaven Pharmaceutical Holding Co. Ltd., a clinical-stage biopharma company with a portfolio of late-stage product candidates targeting neurological and neuropsychiatric diseases, in December announced successful completion of a preplanned interim futility analysis for the T2 Protect AD Study. This study is an ongoing Phase 2/3 clinical trial of troriluzole in Alzheimer’s disease led by the Alzheimer’s Disease Cooperative Study (ADCS) at the medical school of the University of California, San Diego (UC San Diego).
The independent data safety monitoring board communicated that futility was not met based on prespecified criteria for the interim analysis, which evaluated standard cognitive assessments and hippocampal volume on magnetic resonance imaging parameters. The interim analysis was designed specifically to allow for stopping the trial early due to futility.
In order to pass the interim futility analysis, troriluzole had to demonstrate numerically greater benefit over placebo on at least one of the two prespecified criteria at 26 weeks, either cognitive function as measured by the ADAS-cog or hippocampal volume as assessed by magnetic resonance imaging. Biohaven announced that based upon the interim futility and safety analysis that the study would continue.
“Given the tremendous burden of Alzheimer’s disease on patients and families, as well as public health, it is imperative that we rapidly and efficiently study promising new treatments such as troriluzole,” said Dr. Howard Feldman, director of the ADCS and a professor of neurosciences at the UC San Diego School of Medicine, who is principal investigator of the T2 Protect AD Study. “We are very pleased the interim futility analysis supports continuation of the T2 Protect AD Study, and we are hopeful that the trial will demonstrate at its completion that troriluzole ameliorates the symptoms of Alzheimer’s disease.”
Troriluzole is an oral, once-daily tablet that modulates glutamate and is being evaluated as a symptomatic treatment for mild-to-moderate Alzheimer’s disease. The trial is a Phase 2/3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of troriluzole in patients diagnosed with Alzheimer’s disease of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24). Patients are randomized on a 1:1 basis to receive 280 mg of troriluzole or placebo once daily for 48 weeks. The trial is being conducted in collaboration with the ADCS at University of California San Diego School of Medicine.
Noted Dr. Vlad Coric, CEO of Biohaven: “We are encouraged by advancing past the prespecified futility criteria after the first 100 patients completed six months of treatment and we look forward to full results upon study completion. This is an important milestone for our glutamate development program as troriluzole continues to be studied in four pivotal Phase 2/3 trials evaluating its efficacy in multiple neurologic and neuropsychiatric disorders.”