At a Glance
- Lundbeck’s bocunebart (Lu AG09222) shows positive phase IIb PROCEED results for migraine prevention.
- Anti-PACAP mAb targets novel pathway distinct from CGRP therapies.
- IV arm met primary endpoint: significant monthly migraine day reduction in refractory patients.
- Well-tolerated safety profile; phase III planning next.
- Builds on prior HOPE trial data.
Written By: Pharmacally Medical News Desk
Lundbeck has announced promising top-line data from the phase IIb PROCEED trial of bocunebart (Lu AG09222), an investigational anti-PACAP monoclonal antibody for preventing migraine attacks. The intravenous dosing arm met its primary endpoint, showing a statistically significant reduction in monthly migraine days compared to placebo in patients with prior treatment failures.
Trial Design and Population
Lundbeck conducted the PROCEED trial (NCT06323928) was an adaptive phase IIb study evaluating bocunebart’s efficacy, safety, and tolerability via intravenous (IV) and subcutaneous routes in migraine prevention. It randomized 431 patients across 14 countries, including the US, Europe, and Japan, who had 1-4 prior preventive treatment failures in the last decade per ICHD-3 criteria. Patients received monthly IV doses for three months, with the primary endpoint measuring change from baseline in monthly migraine days (MMDs) over weeks 1-12.
Key Efficacy Findings
Bocunebart demonstrated a statistically significant difference versus placebo in reducing MMDs over the 12-week period, highlighting its potential in severe, refractory migraine. While exact reductions and dose-response details await further analysis and conference presentation, the results build on the earlier phase IIa HOPE trial‘s success with single IV dosing. Coordinating investigator Dr. Jessica Ailani noted the efficacy offers hope for patients with this debilitating condition.
Safety Profile
The drug was generally well-tolerated with no new safety signals identified. This aligns with prior data from the HOPE trial, where common adverse events were mild, such as nasopharyngitis and fatigue.
Mechanism and Innovation
Bocunebart (Lu AG09222) is a selective humanized monoclonal antibody (mAb) originally developed by Alder Biopharmaceuticals and now advanced by Lundbeck. Bocunebart targets pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide in migraine pathophysiology, via a pathway distinct from anti-CGRP therapies like Lundbeck’s Vyepti. This novel mechanism positions it as a potential new class for patients unresponsive to existing preventives.
Lundbeck plans additional dose-response analyses and discussions with regulators on phase III designs. Full results will be shared at an upcoming conference and in publications.
EVP Johan Luthman emphasized its role in addressing unmet needs in severe migraine.
Migraine affects over 135 million in G7+China, causing substantial personal and economic burden. With many patients failing current options, bocunebart could expand preventive choices, complementing IV therapies like Vyepti, which saw $710M in 2025 sales.
Reference
Lundbeck announces positive phase IIb top-line results with bocunebart (Lu AG09222; anti-PACAP mAb) in migraine prevention, 12 February 2026, https://news.cision.com/h–lundbeck-a-s/r/lundbeck-announces-positive-phase-iib-top-line-results-with-bocunebart–lu-ag09222–anti-pacap-mab–,c4307114
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments, ClinicalTrials.gov ID NCT05133323, https://clinicaltrials.gov/study/NCT05133323
A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (PROCEED), ClinicalTrials.gov ID NCT06323928, https://clinicaltrials.gov/study/NCT06323928