Lundbeck Advances Bocunebart to Phase III After Positive PROCEED Results

Lundbeck will move its migraine prevention candidate bocunebart (Lu AG09222) into Phase III development following encouraging Phase IIb data from the PROCEED trial (NCT06323928).

In the study, intravenous bocunebart met its primary endpoint, demonstrating a statistically significant reduction in monthly migraine days over 12 weeks compared with placebo in patients who had experienced one to four prior preventive treatment failures. Detailed numerical data have not yet been disclosed. The anti-PACAP monoclonal antibody was generally well tolerated, with no new safety concerns identified.

The results build on the earlier Phase IIa HOPE trial (NCT05133323), which also met its primary endpoint and showed clinically meaningful reductions in migraine days. Lundbeck plans to consult regulators on Phase III design and further analyse dose-response relationships before presenting full data at a scientific meeting.

Despite setbacks for competitors such as Amgen and Eli Lilly, the global migraine market is projected to grow substantially over the next decade.

15-02-2026