PACAP-Targeting Monoclonal Antibody Reduces Monthly Migraine Days in People With Refractory Migraine
According to results of the intravenous (IV) portion of the phase IIb PROCEED clinical trial (NCT06323928), treatment with bocunebart (Lundbeck, Valby, Denmark) demonstrated a statistically significant reduction in monthly migraine days (MMDs) compared with placebo over 12 weeks in participating adults with migraine and 1 to 4 prior preventive treatment failures in the past 10 years. Bocunebart is an investigational monoclonal antibody targeting the pituitary adenylate cyclase-activating polypeptide (PACAP).
PROCEED is an adaptive, phase 2b dose-finding and route-of-administration trial evaluating bocunebart administered once monthly for 3 months. The IV cohort included 431 patients across 14 countries who met International Classification of Headache Disorders (ICHD-3) criteria for migraine and had documented failure of 1 to 4 preventive therapies within the past 10 years. The primary end point was the mean change from baseline in MMDs over weeks 1 through 12 compared with placebo. The trial also assessed safety and tolerability.
Key findings reported in a statement from Lundbeck include the following:
- Bocunebart demonstrated a statistically significant difference vs placebo in mean change from baseline in MMDs over weeks 1 to 12
- Bocunebart was generally well tolerated, and no new safety signals were identified during the trial.
Bocunebart binds and inhibits PACAP signaling, a pathway distinct from calcitonin gene-related peptide (CGRP)–targeted therapies.
Source: H. Lundbeck A/S. Lundbeck announces positive phase IIb top-line results with bocunebart (LuAG09222; anti-PACAP mAb) in migraine prevention. Lundbeck. Published February 12, 2026. Accessed February 17, 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