Approximately 498 patients will be enrolled for the PROCEED trial to evaluate the efficacy of Lu AG09222 for migraine prevention. Credit: peterschreiber.media/Shutterstock.com.

Biopharmaceutical company H. Lundbeck has initiated the PROCEED Phase IIb study to evaluate the efficacy and safety of Lu AG09222, a potential first-in-class therapy for migraine prevention.

The study follows the successful HOPE Phase IIa proof-of-concept trial, which demonstrated the efficacy of intravenously administered Lu AG09222 for the prevention of migraine.

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PROCEED is a randomised, double-blind, placebo-controlled dose-finding trial that will be conducted across Europe, Japan, and the US.

It aims to establish the optimal dose for future pivotal trials worldwide by assessing four different doses of Lu AG09222 administered subcutaneously once a month for three months.

Approximately 498 patients are expected to be enrolled, with study completion anticipated in the second half of 2025.

Lu AG09222 is an investigational monoclonal antibody (mAb) intended to inhibit pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide implicated in migraine pathophysiology of migraine.

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Lundbeck research and development head, and executive vice-president Johan Luthman said: “Initiation of this Phase IIb trial of Lu AG09222 further progresses our neurology pipeline and emphasises Lundbeck’s commitment to people living with migraine and headache-related disorders.

“The diverse nature of the disease highlights the need for exploring novel therapeutic approaches that can address unmet needs. Lu AG09222 has a good chance of being first-in-class with this interesting mechanism.”

The HOPE Phase IIa trial met its primary endpoint, showing a significant difference from placebo in mean change in monthly migraine days over the first four weeks.

Lu AG09222 was generally well tolerated in clinical trials, confirming the role of PACAP in migraine pathophysiology and supporting the potential of the therapy as a preventive treatment for migraine and possibly other pain-related indications.