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Lundbeck's Groundbreaking Presentation on Bexicaserin

Lundbeck, a prominent biopharmaceutical firm, has announced significant results from their Phase 1b/2a PACIFIC trial involving Bexicaserin, a promising treatment for Drug-Resistant Developmental and Epileptic Encephalopathies (DEEs). This anticipated data will be shared at the 36th International Epilepsy Congress taking place in Lisbon, Portugal from August 30 to September 3, 2025.

Understanding Bexicaserin and its Importance

Bexicaserin has been awarded the FDA's Breakthrough Therapy designation due to its potential in addressing severe forms of epilepsy characterized by frequent and drug-resistant seizures. DEEs represent a challenging set of conditions, often leading to developmental regressions and requiring urgent initiatives to explore effective therapeutic options. As such, the data to be presented underscores its significance in the epilepsy treatment landscape, particularly for those affected by conditions like Dravet syndrome and Lennox-Gastaut syndrome.

The PACIFIC Trial and Open Label Extension

The PACIFIC trial was meticulously designed to evaluate long-term effects, and the collection of data over the last year reveals a median seizure frequency reduction of 59.3% among participants. Remarkably, 55% of study participants experienced a sustained decrease of at least 50% in their seizure activity, indicating the lasting impact Bexicaserin could have on patients' quality of life. According to Lundbeck's EVP of Research and Development, Johan Luthman, this not only demonstrates the treatment's efficacy but also solidifies the foundation for advancing to Phase 3 trials.

In its open-label extension (OLE) phase, the Bexicaserin trial recruited a diverse group of participants and achieved an impressive completion rate exceeding 90%. These statistics further reflect its tolerability and promise, as noted by Lead Investigator Ingrid E. Scheffer from The University of Melbourne. She stated that the impressive retention rates among participants provide a strong indicator of both the efficacy and safety of Bexicaserin for individuals coping with severe epileptic conditions.

Additional Research Highlights

Beyond the primary findings concerning seizure frequency, further data exploring the preclinical implications of Bexicaserin in contexts such as sudden unexpected death in epilepsy (SUDEP) and absence seizures will also be shared at the congress. With research additionally looking into the modulation of seizure-related respiratory arrest, Lundbeck aims to address some of the most challenging aspects of treating epilepsy, representing a leap forward in patient care.

The expanding global Phase 3 study, DEEp, is currently underway and aims to evaluate Bexicaserin's safety and efficacy in a randomized and double-blind manner across various regions, including North America, Europe, Asia, and Latin America. This comprehensive approach ensures a robust understanding of its impact in varied demographics and medical backgrounds.

Preparing for the International Epilepsy Congress

At the upcoming congress, Lundbeck will host several presentations detailing their findings:

1. Long-term Safety and Efficacy of Bexicaserin in DEEs: Poster Presentation, August 31, 2025 1345-1515 WEST 1
2. Role of Central 5-HT2C Receptors: Platform Presentation, August 31, 2025 1430-1500 WEST 3
3. Bexicaserin’s Impact on Absence Seizures: Poster Presentation, August 31, 2025 1345-1515 WEST 4
4. Interim Results from the PACIFIC Trial: Poster Presentation, September 1, 2025 1345-1515 WEST 10

These sessions promise to deliver critical insights into the potentials of Bexicaserin in offering a transformative approach to treating severe epilepsies that impact many families worldwide.

Conclusion

Lundbeck's persistent commitment to advancing healthcare solutions serves as a beacon of hope for patients struggling with rare and severe forms of epilepsy. As they prepare to present at the International Epilepsy Congress, the medical community and advocates alike will be watching closely — waiting for a future where effective treatments like Bexicaserin can profoundly change lives for the better.