#Denmark #Lundbeck #Valby #Migraine #Lu AG09222

Lundbeck Expands PROCEED Trial with New IV Dosing

Lundbeck has recently made significant strides in its ongoing PROCEED trial by expanding the scope to include intravenous (IV) administration of its investigational monoclonal antibody, Lu AG09222. This decision follows a planned interim analysis of the current subcutaneous (SC) dosing phase, which demonstrates that approximately 75% of the planned patient recruitment has been achieved. The PROCEED trial, a Phase IIb adaptive study, aims to explore the effectiveness of Lu AG09222 in preventing migraines, notably in patients who have not found relief from previous preventive treatments.

Understanding The PROCEED Trial

Initiated in March 2024, the PROCEED trial is designed to evaluate various dosages and delivery methods of Lu AG09222, targeting patients experiencing migraine episodes and who have seen failure in one to four anti-migraine treatments within the last decade. With migraine being a prevalent and debilitating neurological condition, the trial reflects Lundbeck's commitment to addressing significant unmet medical needs in migraine management, impacting millions globally.

The study's design includes a randomized, double-blind, placebo-controlled setup and is set to take place across various regions, including Europe, Japan, and the United States. With the recent insights from a prior Phase IIa HOPE trial that evaluated IV dosing of Lu AG09222, Lundbeck is well-positioned to capitalize on this promising data while utilizing their established clinical infusion infrastructure dedicated to migraine care.

Potential Impact of Lu AG09222

Lu AG09222 represents a groundbreaking potential treatment option, offering a novel therapeutic approach aimed at inhibiting the pituitary adenylate cyclase-activating polypeptide (PACAP) pathway, a key player in the development of migraine attacks. This investigational treatment stands out by targeting a mechanism distinct from existing migraine therapies, presenting a significant opportunity to address patient needs effectively.

As per estimates, around 2.5 to 3 million migraine patients in the G7 nations are inadequately treated with currently available medications. The anticipated completion of the PROCEED trial is scheduled for the first half of 2026, followed by a pivotal Phase III trial later that year.

The Burden of Migraine

Migraine is recognized as one of the most common neurological disorders, particularly affecting those under 50 years of age, with an estimated 135 million sufferers across the G7 countries alone. The physical health implications coupled with psychosocial impacts significantly burden those affected, hindering their quality of life. Symptoms often include intense, pulsating headaches and can be accompanied by nausea and extreme sensitivity to light and sound. Consequently, the ongoing search for more effective treatments to alleviate the suffering caused by migraines is imperative.

Conclusion

The further exploration of Lu AG09222 in the PROCEED trial, particularly through intravenous administration, marks a pivotal moment for Lundbeck in their mission to redefine migraine prevention. By innovating treatment paths through rigorous clinical trials, they hope to provide relief to millions while also shaping the future landscape of migraine management. Continued updates will follow as the trial progresses, shedding light on the potential of Lu AG09222 as a first-in-class preventive treatment.