Drug Development, Results

Biohaven steps up big clinical plans for its reformulated ALS generic — now also aimed at anxiety

Biohaven $BHVN put together a tiny test study to see if their drug BHV-0223 — a reformulation of an old ALS drug called riluzole — could tackle a big potential market: clinical grade anxiety sparked by standing up to give a public speech.

Vlad Coric

This qualifies as a DSM-5 condition, and investigators lined up 21 patients and divided them into two groups, one of which got the drug before giving a speech and the other a sugar pill.

With that small of a group, it can be hard to tease out much on efficacy. But the company’s researchers say they recorded an 8.3 point drop in the 100-point visual analogue scale used to gauge their responses. That was good for a p value of 0.056 — not statistically significant by standard measures — which they say was positive “relative to the protocol specified level of p= 0.10.”

And now they plan to go into a much bigger study on anxiety to test the therapy’s full potential.

This is one of those drugs that’s been kicked around in academic studies for some years now, sometimes used alongside ketamine to treat depression. 

Reformulations, like J&J’s nasal version of ketamine, can make a lot of sense. In this case, Biohaven is going after a simple oral drug — approved in 1995 for ALS and now a generic — known to modulate glutamate, with a recognized link to anxiety. They are also studying this as a follow-up drug for ALS, looking to breathe some new branded life into an aging, generic franchise.

Biohaven CEO Vlad Coric — a Yale professor — is setting some big expectations here on a small study for a reheated therapy.

Generalized anxiety disorder affects approximately 6.8 million adults, or 3%, of the U.S. population. Although a common disorder, current medication treatments are not fully effective in half of patients. GAD is characterized by excessive anxiety, uncontrollable worry, restlessness, fatigue, difficulty concentrating, irritability, muscle tension and sleep disturbances. Current medication treatments, including antidepressants, benzodiazepines and beta-adrenergic blockers, can have side effects such as sedation and often are of limited effectiveness.


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