Biohaven announced that its Phase 2/3 study of the investigational oral therapy troriluzole (BHV-4157) in treating symptoms of mild to moderate Alzheimer’s disease (AD) has fully enrolled more than 700 patients.
The T2 Protect AD trial will assess if troriluzole use can protect against or slow memory and cognitive skill loss due to Alzheimer’s, and potentially improve these abilities in patients.
A preliminary analysis of troriluzole’s effects on cognition and brain volume loss, a sign of AD progression, is expected by late December.
“We are extremely grateful to all the trial participants and their families, as well as our trial sites, for helping us achieve this milestone,” said Irfan Qureshi, MD, Biohaven’s vice president of Neurology, said in a press release.
“We believe that troriluzole is a promising potential therapy for people suffering from Alzheimer’s disease and look forward to the study results, including the interim analysis by the end of this year,” he added.
Troriluzole, also known as BHV-4157, is a new compound precursor of riluzole — an approved medication for amyotrophic lateral sclerosis (ALS) — designed to regulate glutamate activity, one of the most abundant and important signaling molecules in the brain. Glutamate works by exciting nerve cells, and under normal conditions, it plays an important role in learning and memory.
Abnormal sensitivity or high levels of glutamate, however, can lead to the overexcitation that can damage and kill nerve cells. Troriluzole acts by lowering glutamate-mediated stimulation. It does so by increasing the reabsorption of glutamate, clearing it from synapses, the point of communication between nerve cells.
Preclinical studies in animal models and post-mortem human brain samples suggest that troriluzole can improve brain cells’ response to glutamate. This further suggests it can help to protect against Alzheimer’s-related brain damage and cognitive problems.
“We are hopeful this study will demonstrate that troriluzole can ameliorate the symptoms of Alzheimer’s disease, by reducing synaptic glutamate through a novel mechanism of action,” said Howard Feldman, MD, a professor at the University of California San Diego School of Medicine and the trial’s principal investigator.
“Glutamate is one of the only clinically validated therapeutic targets for Alzheimer’s disease,” added Feldman, who is also director of the Alzheimer’s Disease Cooperative Study (ADCS), a cooperative project run at the UC San Diego and funded by the National Institutes of Health (NIH) to develop and test candidate Alzheimer treatments.
The T2 Protect AD trial (NCT03605667) is a Phase 2/3, randomized, placebo-controlled trial evaluating troriluzole’s efficacy and safety in treating cognitive symptoms and brain damage in people, ages 50 to 85, with mild to moderate Alzheimer’s. Disease severity will be measured by the Mini Mental State Examination, a test commonly used to assess dementia.
Participants are being randomized to either 280 mg of troriluzole or placebo capsules once daily for 48 weeks. The study includes a screening period of up to 42 days, and a four-week post-treatment observation period.
Troriluzole’s efficacy will be primarily measured by comparing changes in the cognitive abilities of patients treated with troriluzole versus those given placebo from the study’s start (baseline) to week 48.
Cognitive abilities will be assessed using a test called ADAS-Cog 11, which evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, and the ability to conceptualize and execute actions.
The trial is running at several sites across the U.S., and is being conducted by Biohaven in collaboration with the ADCS at UC San Diego. More information about the study and its sites can be found here and here.
“Given the devastating impact of Alzheimer’s disease on patients, their families and the healthcare system, we need to urgently assess novel treatment interventions targeting the underlying pathophysiology of this illness. We are grateful to the ADCS and patients participating in our trial to assess the potential efficacy of our glutamate modulator, troriluzole, in this illness,” said Vlad Coric, MD, Biohaven’s CEO.
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