Danish pharmaceutical company Lundbeck will advance the IV formulation of its migraine prevention drug to phase 3 trials after the successful phase 2b trial, it has announced.
Clinical Trials Arena reports that in the PROCEED study, 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 were not disclosed.
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 had experienced between one and four previous preventive treatment failures in the past 10 years.
Dr Jessica Ailani, Professor of Neurology at MedStar Georgetown University Hospital in Washington, said: “I am encouraged by the positive results from the PROCEED trial. The efficacy demonstrated represents a promising advancement in the treatment of migraine, offering hope to many patients suffering from this debilitating condition.”
Based on the phase 2b success, Lundbeck will approach regulatory authorities to discuss the results and phase 3 design options.
Further 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 I2a 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 2 trial and Eli Lilly terminated the development of its candidate LY3451838 after a phase 2 trial.
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