Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates, today announced that Dr. Richard Granstein, M.D., Chairman of Dermatology at Weill Cornell Medicine in New York City, will initiate an investigator-led clinical trial with a Biohaven CGRP-receptor antagonist for the treatment of plaque psoriasis.
Vlad Coric M.D., Chief Executive Officer of Biohaven commented, "Biohaven's neuroinnovation portfolio is powered by a combination of strong science and patient need. Dr. Granstein is a foremost expert in the CGRP-related biology of dermatological conditions, which has been a focus of his research for nearly two decades. We are committed to following the science of CGRP-receptor antagonism across disease states and Dr. Granstein's pioneering work affirms that neuropeptide CGRP may play a critical role in plaque psoriasis. This scientific foundation, together with a recognized need for more safe and effective treatment options for people suffering with psoriasis, has inspired our meaningful collaboration."
The investigator-led clinical trial will explore whether treatment with one of Biohaven's CGRP-receptor antagonists will reduce the severity of disease and percentage of area affected as measured by patients' Psoriasis Activity Severity Index (PASI) score after 16 weeks of treatment as compared to placebo. In addition, the study will assess the potential impact on itch and patient quality-of-life measures.
Dr. Granstein commented, "The animal models and clinical reports of CGRP in psoriasis suggest that CGRP receptor antagonism could alleviate the severity of disease. This clinical study will enable us to evaluate this therapeutic candidate's efficacy, the findings of which will be the first step in bringing this novel, translational idea to patients. Pathways by which the nervous system exerts regulatory effects on immunity may prove to provide important druggable targets for a range of inflammatory disorders."
Biohaven's CGRP-receptor antagonist platform includes Nurtec™ ODT (rimegepant) and zavegepant. Nurtec ODT™ was approved by the FDA in February 2020 for the acute treatment of migraine. Biohaven filed a supplemental New Drug Application (sNDA) for Nurtec™ ODT (rimegepant) for the preventive treatment of migraine earlier this year which was accepted for review in October 2020. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021.
Zavegepant is a third generation, high affinity, selective and unique, small molecule CGRP receptor antagonist that is structurally distinct from rimegepant. Zavegepant may be suitable for multiple routes of delivery including nasal, subcutaneous, inhalation or oral administration. Positive results were announced in late 2019 from a Phase 2/3 study of intranasal zavegepant in the acute treatment of migraine, and the company plans to initiate an additional Phase 3 study before the end of 2020. Biohaven also initiated a Phase 2 trial with intranasal zavegepant in April 2020 in collaboration with Thomas Jefferson University in Philadelphia, PA, to study the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response in pulmonary function which in some cases can be fatal in COVID-19 patients.