Lundbeck’s migraine prevention drug has shown success in a Phase IIb trial, setting the company up for a Phase III study.
In the PROCEED study (NCT06323928), intravenous (IV) bocunebart (Lu AG09222) met its primary endpoint, demonstrating a statistically significant difference to placebo in the change from baseline in the number of monthly migraine days (MMDs) over 12 weeks in a population that experienced past treatment failures. Exact data from the trial was not disclosed.
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The anti-PACAP monoclonal antibody (mAb) was generally well tolerated, and no new safety signals were detected during the trial.
The study enrolled migraine patients who experienced between one and four previous preventive treatment failures in the past 10 years.
Dr Jessica Ailani, professor of neurology at MedStar’s Georgetown University Hospital, said: “I am encouraged by the positive results from the PROCEED trial. The efficacy demonstrated in this trial represent a promising advancement in the treatment of migraine, offering hope to many patients suffering from this debilitating condition.”
Based on the Phase IIb success, Lundbeck will approach regulatory authorities to discuss the results and Phase III design options.
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By GlobalDataFurther analysis will be completed to understand the dosing-response relationship across the investigated doses. Full data from the study will be shared at an upcoming conference and submitted for scientific publication at a later date.
These data build on findings from the previously successful Phase IIa HOPE trial (NCT05133323) evaluating single IV administration of bocunebart in migraine patients. The study met its primary endpoint, showing a significant difference from placebo in mean change in monthly migraine days over the first four weeks.
That study demonstrated that 32% of patients in the 750mg bocunebart saw a reduction of at least 50% in the number of migraine days per month, compared with 27% of those on placebo. The number of headache days per month reduced by 5.8 days in the higher dose Lu AG09222 group compared with 4.1 days in the placebo group.
Lundbeck had also been investigating a subcutaneous version of the drug; however, the company terminated development of this delivery method last year after prespecified interim analysis showed the therapy was unlikely to succeed.
Other companies, including Amgen and Eli Lilly, have also had issues with their migraine prevention drugs. Amgen’s drug, AMG 301, saw no benefit in a Phase II trial and Eli Lilly terminated the development of its candidate LY3451838 after a Phase II trial.
According to GlobalData, the migraine market is expected to reach $16.4bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) in 2033, up from $9.2bn in 2023.
This growth will be primarily driven by increased prescription of calcitonin gene-related peptide (CGRP) antagonists—monoclonal antibodies (mAbs) for migraine prevention and oral gepants for both acute and preventive treatment.
GlobalData is the parent company of Clinical Trials Arena.
