Danish biopharmaceutical company Lundbeck, specializing in brain health treatments, announced the success of Phase II clinical trials for bocaunbart — an intravenous monoclonal antibody for migraine prevention.
Over the 12-week dose-finding trial, bocaunbart significantly reduced the number of headache days compared to placebo in 430 patients who had previously not responded to preventive therapy. The antibody also demonstrated good tolerability. Lundbeck did not disclose more detailed data, promising to do so at an upcoming conference. The pharmaceutical manufacturer also plans to discuss Phase III trial design options with regulatory authorities.
“The efficacy demonstrated in the study represents a promising step forward in migraine treatment, giving hope to patients suffering from this debilitating condition,” noted trial coordinator Dr. Jessica Ailani.
Bocaunbart represents a potentially new class of drugs with a novel mechanism of action. It inhibits signaling of the pituitary adenylate cyclase-activating polypeptide (PACAP). This is fundamentally different from the mechanism of action of other migraine prevention drugs, which typically target the calcitonin gene-related peptide (anti-CGRP). Lundbeck previously abandoned development of a subcutaneous form of bocaunbart due to its ineffectiveness, focusing instead on the intravenous formulation.
In the migraine prevention field, the company already markets Vyepti for intravenous administration. The treatment, administered every three months, entered the crowded CGRP inhibitor market in 2020 to compete with Amgen (Aimovig), Eli Lilly (Emgality), and Teva (Ajovy). Last year, global sales of Vyepti reached $710 million — a 59% increase from the previous year.
