Lundbeck A/S has announced encouraging new data from the intravenous part of its phase 2b PROCEED trial, showing that investigational migraine prevention treatment bocunebart achieved its primary endpoint.
The company said the drug demonstrated a statistically significant reduction in monthly migraine days over weeks 1 to 12 compared with placebo in patients who had experienced between one and four preventive treatment failures in the past decade.
The findings add to earlier evidence from the HOPE phase 2a trial, which evaluated a single IV dose of bocunebart. Lundbeck reported that the treatment was generally well tolerated and that no new safety concerns emerged during PROCEED.
Dr Jessica Ailani, coordinating investigator and certified headache specialist in Washington DC, 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.”
Dr Johan Luthman, EVP and Head of Research & Development at Lundbeck, explained: “This milestone is a testament to our commitment to advancing brain health with innovative treatments that focus on addressing significant unmet medical needs. These data underline Lundbeck’s ambition to deliver the first PACAP targeting option in migraine prevention.
“With its novel mechanism of action, it has the potential to become an important addition to the migraine treatment paradigm, furthering Lundbeck’s mission to improve outcomes for people living with severe migraine.”
The company plans further analyses to refine understanding of the dose–response relationship across the tested doses. Following the positive outcome, Lundbeck intends to engage with regulators to discuss next steps and potential phase III trial designs.
Results from PROCEED will be presented at an upcoming scientific conference and submitted for publication.
