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Lundbeck Unveils Encouraging Phase 2 Data for Bexicaserin

In a significant development for the treatment of rare childhood-onset epilepsies, Lundbeck presented promising long-term data on their investigational drug, bexicaserin, at the 2025 American Epilepsy Society (AES) Annual Meeting held in Atlanta, USA. This newly unveiled data indicates that patients who begin treatment with bexicaserin can maintain a notable reduction in seizure frequency for up to two years, offering hope for improved management of Developmental and Epileptic Encephalopathies (DEEs).

Overview of DEEs

Developmental and Epileptic Encephalopathies represent a group of severe, rare epilepsies that typically emerge during early childhood. These conditions are characterized by unpredictable and drug-resistant seizures, alongside developmental and intellectual disabilities that demand continuous care from family members. Currently, no anti-seizure medications are universally approved for all DEE subtypes, intensifying the need for effective treatment solutions. The data shared by Lundbeck at the AES meeting highlighted the ongoing challenge that families face due to the unpredictable nature of these seizures, underscoring a pressing demand for innovative therapies.

Bexicaserin's Efficacy

According to the latest results from Lundbeck, patients treated with bexicaserin after an initial two years reported a median decrease in countable motor seizures by 60.2% at approximately 18 months and by 53.7% at about 24 months. This consistent reduction was observed across various DEE types, mirroring outcomes from earlier trials conducted within the framework of the PACIFIC trial and its subsequent Open Label Extension (OLE). This indicates that patients who experience an early, clinically significant response to treatment with bexicaserin are likely to sustain this positive outcome over the long term.

The findings reveal no new safety concerns during the two-year treatment period, with the tolerability and safety profiles aligning closely with earlier clinical trial data. Features such as an encouraging safety profile and minimal risk of drug-drug interactions present bexicaserin as a potentially groundbreaking option in this therapeutic landscape.

Insights from Lundbeck Leadership

As Johan Luthman, EVP and Head of Research and Development at Lundbeck, commented, the journey of managing DEEs is laden with emotional and financial challenges. The encouraging results from bexicaserin trials could significantly ease the burden on families struggling with these debilitating conditions. His insights point to a growing optimism that bexicaserin may effectively provide critical seizure control needed for many children affected by these disorders.

The presentation by Lundbeck at the AES Congress was not limited to bexicaserin alone; the company also portrayed a robust pipeline with multiple other presentations showcasing their commitment to enhance outcomes for children suffering from rare and complex epilepsies. This was a significant aspect of their research and development initiatives, aiming at broadening therapeutic options in a space where few alternatives currently exist.

Conclusion

The journey ahead for bexicaserin includes ongoing evaluations within global Phase 3 clinical programs. As Lundbeck continues to explore the compound’s potential, the company has received Breakthrough Therapy designation from the FDA for treating seizures associated with DEEs in patients aged two years and older.

Bexicaserin is not yet approved for marketing by any regulatory body worldwide, and its efficacy and safety continue to undergo rigorous scrutiny. What remains clear, however, is the urgent need for effective treatments to address the challenges posed by DEEs and the hope that bexicaserin can be a pivotal player in overcoming these barriers. As families and caregivers await further developments, Lundbeck's latest findings present a beacon of hope in the landscape of childhood epilepsy treatments.