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Valby, Denmark, 4 June, 2026 – Lundbeck today announced the first presentation of primary data from the Phase IIb PROCEED trial evaluating bocunebart (Lu AG09222), an investigational monoclonal antibody targeting pituitary adenylate cyclase-activating polypeptide (PACAP), at the American Headache Society (AHS) Congress in Orlando, Florida, USA (4-7 June).
The results from the intravenous dosing part of the PROCEED trial reinforce previously reported positive topline findings and further support the therapeutic potential of targeting the PACAP pathway in prevention of severe migraine. The totality of bocunebart data presented at the congress indicate that bocunebart is effective in participants with one to four previous preventive treatment failures, with particularly notable treatment effect in those with chronic migraine.
“Today’s data mark an important milestone in our efforts to bring forward innovative treatments for people living with migraine, particularly those who continue to experience substantial disease burden despite currently available therapies” said Johan Luthman, EVP and Head of Research and Development at Lundbeck. “The PROCEED results strengthen our confidence in targeting the PACAP pathway and support continued clinical development of bocunebart.”
“I am encouraged by the positive results from the PROCEED trial. Despite advances in migraine management, a substantial proportion of patients still do not achieve adequate disease control with currently available therapies. The efficacy demonstrated with bocunebart highlights the potential of a new therapeutic approach for migraine prevention and offers hope to patients living with this debilitating condition”, said the coordinating investigator of the trial and presenting author, Dr. Jessica Ailani, certified headache specialist, Washington DC.
PROCEED is an adaptive, global Phase IIb trial designed to evaluate the efficacy, safety, and tolerability of bocunebart, while also informing dose selection and route of administration for future pivotal program. In the intravenous part of the trial, 429 participants from 14 countries were treated; 257 and 172 participants received bocunebart and placebo, respectively.
Results from the 12-week intravenous treatment period showed that bocunebart met the primary endpoint, demonstrating a statistically significantly larger reduction from baseline in monthly migraine days over Weeks 1–12 compared with placebo. Patients treated with bocunebart experienced a mean reduction of 4.24 monthly migraine days versus 2.86 days with placebo, corresponding to a treatment difference of 1.38 days (p=0.0178). Bocunebart was generally well tolerated, with no new safety signals identified during the treatment period.
Bocunebart is designed to bind to and inhibit PACAP, a neuropeptide implicated in migraine pathophysiology through pathways distinct from calcitonin gene-related peptide (CGRP). This differentiated mechanism positions bocunebart as a potential alternative treatment option for patients who do not achieve adequate benefit from currently available therapies.
Based on the positive outcomes from the PROCEED trial, Lundbeck is advancing preparations for further clinical development of bocunebart in migraine prevention.
In addition, Lundbeck presents Phase I clinical data evaluating the safety and tolerability of bocunebart when co-administered with ubrogepant in participants with migraine. Together with previously presented data on co-administration with triptans, these findings further support the safety profile of bocunebart when used alongside commonly prescribed acute migraine therapies.
About Lundbeck’s bocunebart scientific presentations at the AHS congress
Targeting PACAP in migraine prevention: Early outcomes from the PROCEED phase 2b trial of bocunebart (Lu AG09222)
Poster presentation: Jessica Ailani
Date: Thursday, June 4, 2026
Time: 6:00 pm – 7:30 pm EDT
Safety and Tolerability of Anti-PACAP Monoclonal Antibody Lu AG09222 when Co-administered with Ubrogepant in Participants with Migraine.
Poster presentation: Amaal Starling
Date: Thursday, June 4, 2026
Time: 6:00 pm – 7:30 pm EDT
About the PROCEED migraine trial
The PROCEED trial assessed the efficacy, safety, and tolerability of bocunebart versus placebo when administered once monthly for three months. The trial was designed to establish the optimal dose and route of administration (subcutaneous and intravenous) of bocunebart. A predefined interim analysis of the subcutaneous part of the PROCEED trial demonstrated futility and triggered enrolment into the intravenous part of the trial. In the intravenous part of PROCEED a total of 429 patients from 14 countries (Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary, Lithuania, Japan, Poland, Romania, Slovakia, Spain, and the United States) were treated. The primary efficacy endpoint was defined as the difference between bocunebart and placebo in mean change from baseline in the number of monthly migraine days over weeks 1 to 12.
The target population for this trial included patients diagnosed with migraine according to the International Classification of Headache Disorders, Third Edition (ICHD-3),1 who had experienced treatment failure with one to four different preventive migraine medications within the past 10 years.
About bocunebart
Bocunebart is an investigational monoclonal antibody (mAb) with a novel mechanism of action. It is designed to bind to and inhibit the signalling of pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide implicated in migraine pathophysiology. This mechanism operates through a pathway distinct from that targeted by anti-calcitonin gene-related peptide (anti-CGRP) therapies. Bocunebart represents a potential new treatment class in migraine prevention and may provide an alternative option for people living with migraine who continue to be severely affected by the condition.
Bocunebart is an investigational drug that is not approved for marketing by any regulatory authority worldwide, and the efficacy and safety of bocunebart have not been established.
About migraine
Migraine is a complex and disabling neurological disease characterized by recurrent attacks of severe headache typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound.1
Migraine is among the most prevalent neurological diseases worldwide and remains the leading cause of disability for people under the age of 50 and the 2nd leading cause of disability.2 The disease has a profound impact on daily functioning, including relationships, social participation, household responsibilities, and work productivity. As migraine frequency and severity increase, attacks become more difficult to control, contributing to greater disease burden and can progress to chronic migraine in the absence of appropriate preventive management.3
Contacts
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About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.
Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.
Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.
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