Too scared to speak in public? Biohaven says it has a drug that can help

The glutamate-modulating drug outperformed placebo in a clinical trial. (freestocks-photos/Pixabay)(freestocks-photos / Pixabay)

Biohaven’s new formulation of amyotrophic lateral sclerosis drug riluzole has helped people with social anxiety face the challenge of speaking in public.

The investigator-led trial—conducted at Yale University School of Medicine—recruited 21 people with social anxiety disorder who were asked to carry out a 10-minute public speaking task after taking its BHV-0223 candidate, an under-the-tongue oral formulation of riluzole, or placebo an hour beforehand.

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The verdict? Biohaven’s glutamate-modulating drug achieved a significant reduction in anxiety based on a 100-point symptom scale, reducing it by eight points compared to placebo, with a 14-point relative improvement from the prespeech baseline.

To double-check the findings, the investigators repeated the test a few days later, to allow for any lingering effects of the drug to dissipate, with the BHV-0223 group switching to placebo and vice versa. The outcome was the same.

“The findings from this anxiety-provoking challenge study in patients with social anxiety disorder demonstrated antianxiety effects of BHV-0223 in a public speaking scenario,” says lead investigator Michael Bloch, M.D., an associate professor at Yale University School of Medicine.

The results “suggest the therapeutic potential of glutamate modulation in the treatment of anxiety disorders,” he added.

For the Connecticut biotech, the positive results add another string to the bow of its BHV-0223 program, which is in midstage clinical testing and is scheduled to be submitted for approval later this year. Biohaven has a wide-ranging license from Yale related to the development and use of riluzole-based products for a variety of central nervous system disorders, including generalized anxiety disorder, social anxiety disorder and panic disorder.

It’s also developing a prodrug of riluzole—formerly called trigriluzole and now known as troriluzole—for obsessive-compulsive disorder and spinocerebellar ataxia, as well as Alzheimer’s disease. The company suffered a setback a few months back, however, when the drug failed to show efficacy in spinocerebellar ataxia, so the new data is a timely boost to its glutamate program. It has since announced plans to start a second trial in that indication before the end of 2018.

Biohaven’s lead program is its CGRP inhibitor rimegepant, which is due for filing next year and is in competition with Allergan’s ubrogepant to be the first oral drug in the class to reach the market. It has two phase 3 trials in hand suggesting rimegepant is better than placebo in alleviating symptoms.

Earlier this week, Biohaven said it had raised $150 million from a deal with Royalty Pharma which gave the latter “low single-digit, tiered, sales-based participation rights” in rimegepant and follow-up compounds. It said the cash will be used to take rimegepant through to regulatory filings, progress follow-up BHV-3500 into phase 2 and support the continued development of its glutamate drugs.

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