Troriluzole, an investigational oral therapy by Biohaven, shows a potential to improve cognition and lessen brain volume loss, a sign of Alzheimer’s disease progression, a board reviewing the ongoing Phase 2/3 trial decided.
The trial successfully completed its interim futility analysis — meaning it can efficiently reach preset goals measuring benefit — and can continue treating patients toward that end, its independent Data Safety Monitoring Board found.
“We believe that troriluzole is a promising potential therapy for people suffering from the devastating impact of Alzheimer’s disease,” Irfan Qureshi, vice president of neurology at Biohaven, said in a press release. “We are very excited that the T2 Protect AD Study, which recently completed enrollment, has now passed the interim futility analysis.”
Trigriluzole (BHV-4157) is a new compound precursor of riluzole — an approved amyotrophic lateral sclerosis (ALS) treatment — designed to regulate glutamate activity, one of the most abundant and important signaling molecules in the brain.
Unusual sensitivity to glutamate — or excessively high levels of this molecule — can damage and kill nerve cells.
Troriluzole acts by increasing the expression and function of EAAT2, a transporter that is used by brain cells to reabsorb glutamate, removing it from the synapse — the junction between two nerve cells that allows them to communicate. Preclinical studies in animal models and human brain tissue samples suggest its use improves brain cell response to glutamate, protecting them.
The T2 Protect AD trial (NCT03605667) is a Phase 2/3, placebo-controlled study evaluating troriluzole’s safety and efficacy to treat cognitive symptoms and prevent brain volume loss, a sign of AD progression, in more than 700 people, ages 50 to 85 years, with mild to moderate Alzheimer’s. Fully enrolled, it is due to finish in December 2020.
Disease severity is being measured using the Mini Mental State Examination, a test commonly used to help assess dementia.
Patients are randomized to receive either 280 mg of troriluzole or placebo capsules once daily for 48 weeks (about one year).
To pass its interim futility analysis, the trial had to demonstrate benefit over placebo regarding either cognitive function (as measured using the Alzheimer’s Disease Assessment Scale Cognitive Subscale) or hippocampal volume — a measure of brain volume loss assessed by magnetic resonance imaging — over 26 weeks.
Data covering 100 patients who had completed the required six months of treatment were evaluated by the monitoring board.
“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,” said Vlad Coric, the CEO of Biohaven.
“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 Howard Feldman, 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,” added Feldman, who is also the director of the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California San Diego School of Medicine.
T2 Protect AD Study is being led by ADCS in collaboration with Biohaven.
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