Biohaven Pharmaceutical Holding Co Ltd (NYSE:BHVN) just announced initial positive results from its ongoing long-term, open-label safety study of its oral calcitonin gene-related peptide (CGRP) receptor antagonist, rimegepant, for the acute treatment of migraine. This has been a red-hot stock following action out of the ASH conference last week, so tomorrow’s reaction will be interesting.

According to the release, “based upon this interim analysis (database cutoff of November 21, 2018) of Study BHV3000-201 (NCT03266588 or “Study 201”) it appears that rimegepant may be safe and well tolerated with long-term dosing in patients with migraine. In this study, patients are allowed to treat migraine attacks of all severities (mild to severe) up to once daily for up to a full year. The interim results also include hepatic safety and tolerability data of rimegepant 75 mg in study participants based upon review of both adverse events and regularly scheduled liver function tests.  Interim hepatic data were reviewed by an external independent panel of liver experts. The panel provided a consensus opinion based upon the Drug-Induced Liver Injury Network (DILIN) causality assessment. The panel did not assess any liver cases as probably related to study drug and there were no Hy’s Law cases identified. The panel concluded that there was no liver safety signal detected through the data analysis cut-off date, including in a subset of patients with near-daily dosing (³ 15 doses/month). In aggregate, the panel noted that, compared to placebo arms of other migraine treatments, there was a very low incidence of overall elevations of liver laboratory abnormalities (1.0% incidence of serum ALT or AST > 3xULN). Subjects will continue to participate in Study 201 with additional data analyses to be submitted to the FDA in connection with the planned filing, including the required 120-day safety update.”

Biohaven Pharmaceutical Holding Co Ltd (NYSE:BHVN) bills itself as a clinical-stage biopharmaceutical company that develops product candidates to treat neurological diseases, including rare disorders.

Its lead product candidate is rimegepant, which is in Phase III clinical trials for the acute treatment of migraine.

The company also develops trigriluzole, which is in a Phase II/III clinical trial used for the treatment of ataxias with an initial focus on spinocerebellar ataxia; and Phase II/III clinical trial for the treatment of obsessive compulsive disorders, as well as for the treatment of Alzheimer’s diseases.

In addition, it develops BHV-3500 for the acute treatment and prevention of migraine; BHV-0223 for the treatment of amyotrophic lateral sclerosis, a neurodegenerative disease that affects nerve cells in the brain and spinal cord; and BHV-5000 for the treatment of symptoms associated with Rett syndrome, such as breathing irregularities.

BHV-0223 is a sublingually administered, orally dissolving tablet (ODT) that makes use of the unique Zydis ODT fast-dissolve technology. It is being developed under an exclusive worldwide agreement with Catalent. While riluzole is FDA-approved for ALS, existing formulations consist only of an oral tablet taken with water or an oral suspension (thickened liquid). BHV-0223 is designed to be placed under the tongue where it dissolves in seconds and is absorbed by the vasculature, thereby eliminating the need for swallowing.

The company was founded in 2013 and is based in New Haven, Connecticut. Biohaven Pharmaceutical Holding Company Ltd. is a subsidiary of Portage Biotech Inc.

 

Riding High

As we discussed earlier, BHVN just announced initial positive results from its ongoing long-term, open-label safety study of its oral calcitonin gene-related peptide (CGRP) receptor antagonist, rimegepant, for the acute treatment of migraine.

BHVN has had a rough past five days of trading action, with shares sinking something like -5% in that time. However, this follows a monster rip early last week.

Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, “The totality of the interim results from this long-term dosing trial with rimegepant provides important safety information for our planned NDA submission and also preliminary proof of concept for pursuing rimegepant for both the acute and preventive treatment of migraine. The clinical outcomes and data from this long-term study to date are particularly meaningful because of the large number of patients who took rimegepant to treat migraine as they would in the real-world, allowing patients to treat every migraine attack, even if mild, up to once daily for one year.  We believe rimegepant has the potential to truly improve the lives of patients who suffer from debilitating migraine and we look forward to submitting the NDA for this promising new treatment option in 2019.”

Biohaven Pharmaceutical Holding Co Ltd (NYSE:BHVN) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($168.2M against $15.3M).

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