Biohaven Pharmaceutical has enrolled the first patient in a Phase II/III trial to evaluate its intranasally administered third-generation CGRP receptor antagonist BHV-3500 for the treatment of migraines.
In the double-blind, randomised, placebo-controlled, dose-ranging trial, 5mg, 10mg and 20mg doses of BHV-3500 are being compared to placebo to treat a migraine attack.
The third-generation calcitonin gene-related peptide (CGRP) receptor antagonist BHV-3500 is currently being developed by Biohaven.
The trial will enrol about 400 randomised subjects per treatment arm and will provide proof of efficacy on the regulatory endpoints of pain freedom and freedom from the migraine-associated symptom at two hours after giving the dose.
Biohaven Pharmaceutical CEO Vlad Coric said: “BHV-3500 is complementary to our lead migraine asset, rimegepant, which has met the primary efficacy endpoints in three completed Phase III clinical trials, with a favourable safety profile.
“We believe that intranasal BHV-3500 may provide people with ultra-rapid onset of migraine relief in a form that can easily be self-administered whenever and wherever a migraine strikes.”
Intranasal BHV-3500 is administered using the FDA-approved Aptar Pharma Unit Dose System (UDS) designed to enable systemic delivery of drugs.
The Phase I trial used the Aptar Pharma UDS device and maintains consistency of dosing throughout the clinical development programme of BHV-3500.
The fill/finish manufacturing of BHV-3500 will be completed by Catalent Pharma Solutions, which will also assemble the Aptar intranasal devices for Biohaven's clinical trials.
BHV-3500 is the second product candidate in Biohaven's NOJECTION migraine platform and its physicochemical properties make it potentially suitable for multiple routes of delivery, including nasal, inhalation or oral administration.
In August last year, Biohaven reported positive data from a clinical trial investigating the effect of BHV-0223 to treat patients with social anxiety disorder.