Biohaven Pharmaceutical ( BHVN Quick Quote BHVN - Free Report) announced dismal preliminary data from a focused analysis of the top-line co-primary and key secondary endpoints of a phase II/III study evaluating its pipeline candidate — troriluzole — as symptomatic treatment for mild-to-moderate Alzheimer's disease (AD).
Preliminary data from the study demonstrated that the candidate failed to achieve statistical improvement in primary endpoints — Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) — compared to placebo. The candidate also did not differentiate from placebo in measure of hippocampal volume assessed by magnetic resonance imaging, the study’s key secondary endpoint, in the overall patient population. Data suggest that the candidate is not effective as a symptomatic treatment in a mixed population of patients with mild and moderate AD.
Biohaven’s shares declined almost 7.5% on Jan 18 following the news. However, stock of the company has gained 51.6% in the past year compared with the
industry’s increase of 11.1%.
Meanwhile, the company noted that troriluzole achieved numerical difference of a potential benefit, although non-significant, in a subgroup analysis consisting only of mild AD patients. However, detailed study data including additional secondary and exploratory efficacy analyses and biomarker data are expected in the coming months.
The company awaits additional data from the phase II/III study to analyse the potency of the candidate in early AD as a disease modifying agent. The company will also decide the future course of troriluzole development in AD patients based on these data.
We note that AD is one of the toughest diseases to be treated. While there is no cure for the disease yet, there are a few drugs approved by the FDA that can help control the symptoms of AD. Successful development of therapies for treating Alzheimer’s disease is challenging due to the risk of adverse events. However, the AD market has attracted a lot of attention from several biggies in the pharma/biotech space, given its market potential.
Biogen ( BIIB Quick Quote BIIB - Free Report) is one of the leading contenders in the AD segment and has several candidates in pipeline targeting AD indication. The company has faced failure when its controversial AD candidate, aducanumab, failed to receive recommendation for approval from an FDA advisory committee. An FDA decision is expected in March 2021. The company has another AD candidate, BAN2401, which is being evaluated in a phase III study for preclinical (asymptomatic) AD. Several other companies have terminated their AD programs following years of failure including Merck ( MRK Quick Quote MRK - Free Report) and Pfizer ( PFE Quick Quote PFE - Free Report) .
Please note that Biohaven is also developing troriluzole as potential treatment for ataxias and
obsessive-compulsive disorder. Zacks Rank
Biohaven currently carries a Zacks Rank #3 (Hold). You can see
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