Key Takeaways
- Lundbeck’s intravenous monoclonal antibody has successfully met its primary goal in a phase 2b migraine prevention study.
- The dose-finding trial indicated a statistically significant reduction in monthly migraine days compared to placebo among 431 patients.
- The company is preparing to discuss phase 3 study options with regulators and will present detailed data at an upcoming conference.
Positive Phase 2b Results for Lundbeck’s Migraine Treatment
Lundbeck has reported promising results from its phase 2b trial of an intravenous monoclonal antibody aimed at preventing migraines. The drug, known as bocunebart (Lu AG09222), demonstrated a significant reduction in monthly migraine days (MMDs) among participants who had not found relief with previous preventative treatments.
In this study, which included 431 patients, the company found a statistically significant difference in MMDs compared to a placebo over a 12-week period. Although Lundbeck has yet to publicly release detailed data on these results, they indicated that participants well tolerated the investigational treatment. The company plans to unveil more extensive data at an upcoming conference.
Following these findings, which focused on the intravenous dosing part of the trial, Lundbeck aims to engage with regulators to discuss potential phase 3 study designs. Johan Luthman, Ph.D., EVP and head of R&D at Lundbeck, expressed excitement over the findings, stating that they reflect the company’s commitment to introduce a new PACAP-targeting option for migraine prevention. He noted the drug’s potential to significantly enhance treatment outcomes for patients experiencing severe migraines.
The trial originally commenced in 2024 to identify the most effective method of administration for bocunebart. While the intravenous method showed success, development of a subcutaneous delivery option was halted last year after a planned interim analysis indicated futility in that approach.
Subcutaneous administration has presented challenges for other pharmaceutical companies in the migraine treatment arena as well. For instance, Amgen reported no significant benefit of its monoclonal antibody targeting the PAC1 receptor against placebo, and Eli Lilly discontinued its anti-PACAP antibody’s development after phase 2 trials.
In addition to bocunebart, Lundbeck also competes in the crowded CGRP inhibitor market with its drug Vyepti, which has been available since 2020. Vyepti is administered every three months and aims to compete with established subcutaneous treatments from Amgen, Eli Lilly, and Teva. Remarkably, Vyepti generated $710 million in worldwide sales last year, reflecting a significant growth of 59% compared to 2024.
Overall, Lundbeck’s recent phase 2b results underscore the company’s innovative approach and determination to bring new and potentially effective treatments to the migraine prevention landscape. As new data becomes available, it will further clarify the role of bocunebart in alleviating migraine symptoms for those who struggle with this debilitating condition.
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