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Lundbeck to Present Promising Data on Bexicaserin at Upcoming Congress

In an exciting development for epilepsy research, H. Lundbeck A/S will present new findings on bexicaserin, an innovative treatment under investigation for Developmental and Epileptic Encephalopathies (DEEs). This presentation will take place at the 36th International Epilepsy Congress (IEC), held from August 30 to September 3 in Lisbon, Portugal. This groundbreaking data will shine a light on its long-term impact on seizure frequency in patients suffering from this rare form of epilepsy.

The PACIFIC trial, a Phase 1b/2a study, has provided key insights into the efficacy of bexicaserin. The trial includes an open label extension (OLE) segment, where the results reveal that patients experienced a median reduction of 59.3% in countable motor seizure frequency. Notably, 55% of participating individuals reported sustained reductions of 50% or more in seizures compared to their baseline measurements prior to the trial.

Bexicaserin has garnered attention not only for its potential effectiveness but also for its safety profile. According to Johan Luthman, EVP and Head of Research and Development at Lundbeck, the treatment is well-tolerated, with no new safety signals presenting during the OLE study. “As we progress into Phase 3 trials, the clinical data to date indicates broad and durable anti-seizure activity across DEEs, revealing our commitment to transforming care for these patients,” said Luthman.

The PACIFIC trial has included both children and adults, focusing specifically on those engaging in effective treatment options. Lundbeck's findings are particularly impactful because DEEs represent some of the most severe forms of epilepsy, often characterized by drug-resistant seizures and developmental delays. Patients with these conditions have limited treatment avenues available to them, highlighting the significance of new therapies like bexicaserin.

Dr. Ingrid E. Scheffer, the Lead Investigator and Professor of Pediatric Neurology at The University of Melbourne, expressed her optimism regarding bexicaserin’s potential: “The completion rate of over 90% in our study signifies not only the tolerability but also the extended effectiveness of the treatment across diverse types of DEEs.”

In addition to the primary data from the PACIFIC trial, Lundbeck will share supplementary information based on preclinical findings related to sudden unexpected death in epilepsy (SUDEP). This additional research will explore the effects of bexicaserin on seizures as well as respiratory arrest in an audiogenic seizure model.

The investigational compound is currently in late-stage clinical development through its global Phase 3 DEEp program, which aims to further assess its efficacy and safety for children and adults with DEEs. The trial comprises several components, including the ongoing DEEpSEA trial for patients with Dravet syndrome and the DEEpOCEAN trial for individuals with various DEEs, including Lennox-Gastaut syndrome.

Both clinical trials follow rigorous protocols, including randomized, double-blind, placebo-controlled methodologies to ensure the integrity of the findings. Participants are being recruited across North America, Europe, Asia, Australia, and Latin America, marking a comprehensive international effort to evaluate this promising therapy.

Bexicaserin (LP352) acts as an oral central 5-HT2C receptor superagonist, minimizing cardiovascular toxicity risks associated with less selective serotonergic agents. Although bexicaserin has yet to receive any regulatory approval worldwide, it has been designated as a Breakthrough Therapy by the FDA, emphasizing its potential to address the unmet needs in treating DEEs. Lundbeck’s commitment to battling epilepsy highlights their focus on neurological health and the ongoing pursuit of innovative treatments.

For further insights, attend Lundbeck’s session at IEC, where they will provide detailed discussions on their findings, including:

• - Long-term Safety, Tolerability, and Efficacy of Bexicaserin for the Treatment of SEIZURES, presented on August 31.
• - Activation of Central 5-HT2C Receptors by Bexicaserin in relation to seizures and respiratory arrest.
• - The impact of Bexicaserin on GAERS Absence Epilepsy, showcasing its multi-faceted approach to tackling seizure management.

Lundbeck is dedicated to pushing the boundaries of neurological and psychiatric research, ensuring long-term value for patients and advocating to close gaps in epilepsy care. With more than 70 years of experience in brain health, their aim is clear: to make a meaningful difference in the lives of individuals battling epilepsy and other neurological disorders.

For the latest updates and information about Lundbeck's innovative approaches, visit their official site at www.lundbeck.com.