Lundbeck preps phase 3 for migraine prevention drug

Lundbeck seems to have brought its migraine prevention drug bocunebart back on track, after dropping development of one formulation of the anti-PACAP antibody last year.

Results from the phase 2b PROCEED trial of intravenous bocunebart (also known as Lu AG09222) showed that the drug was able to cut the number of monthly migraine days (MMD) compared to placebo, with a dose-response relationship, in a group of patients who had failed earlier treatments.

Denmark-based Lundbeck hasn't revealed the data behind its update, but said it was sufficiently encouraged to seek discussions with regulators about the design of a phase 3 programme that could support regulatory filings for bocunebart as a potential first-in-class option for migraine prevention.

The trial enrolled around 430 patients who had experienced one to four preventive treatment failures in the past 10 years and were followed up for 12 weeks. Along with a statistically significant reduction in MMD, bocunebart was also "generally well tolerated," according to Lundbeck, with no new safety signals.

PACAP is a neuropeptide implicated in the pathophysiology of migraine and has emerged as a novel target that could complement other treatment approaches, such as drugs targeting CGRP and serotonin.

In March 2025, Lundbeck revealed that it was switching to an IV version of the anti-PACAP drug after an earlier phase of PROCEED did not support continued development of a subcutaneously-injected formulation.

"These data underline Lundbeck's ambition to deliver the first PACAP targeting option in migraine prevention," said Dr Johan Luthman, head of R&D at Lundbeck. "With its novel mechanism of action, it has the potential to become an important addition to the migraine treatment paradigm."

Earlier efforts to target the PACAP pathway in migraine resulted in failure, with Amgen abandoning work on its PAC1 receptor-targeting antibody vipalanebart (AMG 301) in 2020, while Lilly's anti-PACAP antibody LY3451838 generated disappointing results in a phase 2 trial and was scrapped in 2022.

Lundbeck already markets an IV CGRP inhibitor administered every three months – Vyepti (eptinezumab) – which has been growing strongly, with sales up more than 50% to DKK 4.48 billion ($711 million) last year.

The sales growth is remarkable, given how crowded the migraine prevention market is at the moment, with multiple injectable and oral CGRP inhibitors available from Amgen, Eli Lilly, Teva, AbbVie, and Pfizer.

GlobalData has previously predicted that the overall migraine market – including drugs for prevention and treatment – will reach more than $16 billion in the top seven pharma markets by 2033.