Biohaven Pharmaceutical ( BHVN Quick Quote BHVN - Free Report) announced initiation of enrollment in a pivotal phase III study to evaluate its third-generation glutamate modulating agent, troriluzole, in patients with obsessive-compulsive disorder (OCD).
The late-stage study will evaluate 280 mg once daily dose of troriluzole as adjunctive treatment for OCD patients who had an inadequate response to existing standard of care treatment. The company is planning another identical phase III study to evaluate the candidate.
The company has completed a phase II proof of concept study on troriluzole in OCD patients. Although data from the study did not demonstrate statistical significance for the candidate, it helped the company in refining the design of its phase III study. The company has increased sample size and is evaluating a higher dose in the late-stage study. It has also optimized study design to minimize placebo effect.
Per the press release, OCD affects almost a million people in the United States and the serious psychiatric condition significantly impacts quality of life. Current treatment options offer minimal benefit to 20-30% of patients. Patients also continue to experience significant residual symptoms following treatment.
Successful development of troriluzole as adjunctive treatment for OCD will be beneficial for the company due to the unmet opportunity in the segment. Moreover, there are a few companies engaged in developing OCD therapies. However, development of drugs for neurological diseases had been dismal.
Biohaven is also developing troriluzole as potential treatment for ataxias and Alzheimer’s disease.
Biohaven’s shares have gained 52.4% in the past year compared with the
industry’s rise of 5.2%.
We note that Biohaven has one commercial drug, Nurtec ODT, in its portfolio. The drug was approved by the FDA in February 2020 for treating acute migraine. The drug generated sales of $28.5 million in the first nine months of 2020. The drug has shown strong growth on the back of increase in market share of Nurtec in the rapidly growing oral CGRP segment. However, it faces stiff competition from other approved anti-CGRP drugs from well-established pharma companies including
Teva’s ( TEVA Quick Quote TEVA - Free Report) Ajovy, AbbVie’s ( ABBV Quick Quote ABBV - Free Report) Ubrelvy, Lilly’s ( LLY Quick Quote LLY - Free Report) Emgality and Amgen’s Aimovig. Among these approved drugs Ubrelvy is the only other oral anti-CGRP drug.
Meanwhile, Biohaven is seeking a label expansion of Nurtec to include preventive treatment of migraine. It has filed a supplemental new drug application for the same and a decision is expected in in the second quarter of 2021.
Biohaven is also evaluating Nurtec forf trigeminal neuralgia in a phase II study. Meanwhile, the company is developing another CGRP antagonist zavegepant for the acute treatment of migraine as well as for non-migraine indications.
Biohaven currently carries a Zacks Rank #3 (Hold). You can see
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