Biohaven Pharmaceutical Holding Co Ltd (NYSE:BHVN) just released positive topline results from a randomized, controlled Phase 3 clinical trial (BHV3000-303 or Study 303) evaluating the efficacy and safety of its Zydis orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine. On its face, this looks good.
According to the release, in Study 303, rimegepant Zydis ODT statistically differentiated from placebo on the two co-primary endpoints as well as the first 21 consecutive primary and secondary outcome measures that were prespecified in hierarchical testing. Consistent with the two previous Phase 3 clinical trials, Study 303 met its co-primary registrational endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours using a single dose.
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.
We started off by noting that BHVN just hit the wires with the announcement of positive topline results from a randomized, controlled Phase 3 clinical trial (BHV3000-303 or Study 303) evaluating the efficacy and safety of its Zydis orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine.
According to the release, “Importantly, patients treated with the rimegepant Zydis ODT formulation began to numerically separate from placebo on pain relief as early as 15 minutes, and this difference was statistically significant at 60 minutes (p < 0.0001) (Figure 1). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo (p = 0.0025). Lasting clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p < 0.0001), pain relief (p < 0.0001), freedom from the most bothersome symptom (p = 0.0018), and freedom from functional disability (p < 0.0001). Superiority over placebo was also demonstrated in multiple other secondary endpoints. The vast majority of patients treated with rimegepant Zydis ODT (85%) did not use any rescue medications.”
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).
Vlad Coric, M.D., Chief Executive Officer of Biohaven, stated, “Fast-acting and long-lasting pain relief in an easy to use formulation is important to patients. Rimegepant provides these characteristics and we believe is the first oral CGRP receptor antagonist to report superiority over placebo on pain relief and return to normal functioning by 60 minutes. These results, combined with the previous data from the two prior Phase 3 trials, reinforce the potential of rimegepant to be an important new and differentiated option for the acute treatment of migraine.”