Biohaven Pharmaceutical has received notification from the independent Data Safety Monitoring Board (DSMB) to continue its Phase II/III T2 Protect AD study of troriluzole for the treatment of mild-to-moderate Alzheimer’s disease.
The DSMB communication follows a pre-planned interim futility analysis intended to review cognitive measures and hippocampal volume.
Biohaven said that the drug has passed the futility review, which requires numerically greater benefit at 26 weeks on one of the two pre-specified criteria when compared to placebo.
The pre-specified criteria are cognitive function determined with the ADAS-cog and hippocampal volume evaluated using magnetic resonance imaging.
T2 Protect AD Study principal investigator Howard Feldman said: “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.
“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 investigational, oral, once-daily medication designed to modulate and normalise the synaptic levels of glutamate, which is said to be the most abundant excitatory neurotransmitter in the body.
It works by enhancing glutamate uptake from the synapse. The drug is being developed as a symptomatic therapy for mild-to-moderate Alzheimer’s.
The randomised, double-blind, placebo-controlled Phase II/III T2 Protect AD study is investigating the safety and efficacy of a 280mg dose of the drug administered daily for 48 weeks.
T2 Protect AD study is being led by the University of California San Diego School of Medicine’s Alzheimer’s Disease Cooperative Study (ADCS).
Troriluzole is also being studied in various other neurologic and neuropsychiatric conditions.