H. Lundbeck A/S (Lundbeck) announced the advancement of the clinical development of Lu AG09222 for migraine prevention with the initiation of PROCEED, a randomized, double-blind, phase IIb, dose-finding trial to assess efficacy and safety of multiple subcutaneously administereddoses. The PROCEED trial builds on the positive results of the HOPE phase IIa Proof-of-Concept trial demonstrating efficacy of intravenously administered Lu AG09222 in migraine prevention. Lu AG09222 is an investigational monoclonal antibody (mAb) with an innovative mode of action.

It is designed to bind and inhibit signaling mediated by pituitary adenylate cyclase-activating polypeptide (PACAP); a neuropeptide that is implicated in migraine pathophysiology. Lu AG09222 may offer a potential treatment option in a new treatment class for people with migraine. It is directed at a migraine pathway that is distinct from the pathway targeted by the recently introduced anti-calcitonin gene-related peptide (anti-CGRP) treatment approach.