Suffering from debilating headache? Fret not.
Pharma innovator H Lundbeck has announced that its experimental migraine treatment, bocunebart (Lu AG09222), has delivered positive top-line results in the phase IIb PROCEED trial, meeting its primary endpoint.
The intravenous (IV) portion of the study demonstrated a statistically significant reduction in monthly migraine days compared to placebo in patients with a history of prior preventive treatment failures.
The trial enrolled 431 patients across 14 countries, targeting those who had failed 1-4 preventive migraine therapies in the past decade. Bocunebart was generally well tolerated, with no new safety concerns observed.
“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,” said Jessica Ailani, coordinating investigator and certified headache specialist, Washington DC.
Bocunebart works by blocking pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide implicated in migraine, offering a novel mechanism distinct from current anti-CGRP therapies.
“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,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck.
Bocunebart, still an investigational therapy, represents a potential new class of migraine preventive treatment and could offer a lifeline for patients severely affected by this debilitating condition.
