#Denmark #Lundbeck #Valby #Lu AG09222 #migraine prevention

Lundbeck Broadens Administration Research for Lu AG09222

In a significant move toward advancing migraine treatment, H. Lundbeck A/S has announced the expansion of its clinical trial framework for Lu AG09222, an investigational monoclonal antibody (mAb) targeting the pituitary adenylate cyclase-activating polypeptide (PACAP). This decision follows a pre-specified interim analysis of the ongoing PROCEED trial, which has successfully enrolled approximately 75% of its participants under the subcutaneous (SC) administration route. Now, the trial will advance to explore dosage and efficacy using intravenous (IV) administration as well.

Background of the PROCEED Trial

The PROCEED trial serves as an adaptive Phase IIb investigation designed to evaluate the safety, efficacy, and tolerability of Lu AG09222. Targeting patients who have not responded adequately to one to four preventive migraine treatments within the last decade, Lundbeck aims to address the sizeable unmet medical need for better migraine management options. Despite recent improvements in treatment options, millions remain inadequately treated, highlighting the necessity for innovative solutions like Lu AG09222.

Pacap has drawn attention as a potential contributor to migraine pathophysiology, presenting a novel target distinct from the well-explored CGRP pathway in migraine therapies.

Future Directions for Lu AG09222

This expansion marks a pivotal moment for Lundbeck, allowing the company to leverage its previously validated clinical infusion infrastructure to investigate IV administration of Lu AG09222. The shift to IV administration aims to provide deeper insights into the dosage-response relationship, further building on findings from the earlier HOPE Phase IIa trial.

Lundbeck plans to complete the PROCEED trial by mid-2026, with a pivotal Phase III trial expected to commence in the latter half of the same year. This timeline positions Lundbeck at the forefront of research aimed at providing patients with better migraine prevention options, transforming Lu AG09222 into a first-in-class treatment option.

Health Impact of Migraines

Migraine is a debilitating neurological disorder characterized by recurring episodes of varying intensity, often accompanied by nausea, vomiting, and sensitivity to light and sound, impacting around 135 million people in developed G7 nations plus China. For many, the condition poses significant social and economic burdens, stressing the importance of effective preventive measures.

The PROCEED trial highlights Lundbeck's commitment to advancing brain health and improving the lives of those affected by complex neurological conditions. By targeting a distinct neuropeptide implicated in migraine, Lundbeck hopes to develop an effective treatment that fills the existing gaps in current therapy options. With a dedicated clinical approach, the company aims for Lu AG09222 to be a game-changer in the realm of migraine medicine, ultimately improving the quality of life for countless individuals worldwide.

Conclusion

As the PROCEED trial progresses, the upcoming results from the investigations into Lu AG09222’s effectiveness through different administration routes could resonate throughout the field of migraine treatment, potentially providing new hope and opportunities for those battling this multifaceted condition. Lundbeck's initiative not only underscores their pioneering spirit in neurobiological innovation but also reinforces their dedication to addressing the complex challenges associated with migraine prevention.