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Lundbeck to Present Groundbreaking Data on Bexicaserin

At the upcoming 2025 American Epilepsy Society (AES) Annual Meeting, H. Lundbeck A/S will showcase new information about bexicaserin (LP352), an investigational treatment aimed at combatting seizures related to Developmental and Epileptic Encephalopathies (DEEs). As a group, DEEs are characterized by severe onset in childhood, often resulting in drug-resistant seizures and profound developmental disabilities. This year, Lundbeck aims to shed light on the promising effects of bexicaserin, which has been shown to lead to significant reductions in seizure frequency as quickly as two weeks post-treatment.

Understanding DEEs

DEEs encompass a variety of severe epilepsy syndromes that actively resist conventional anti-seizure medications (ASMs). As a result, patients with these conditions frequently exhibit not only seizures but also substantial developmental delays and intellectual disabilities, rendering them highly dependent on caregivers. According to recent reports, only a limited number of DEE types currently have approved treatments, leaving many patients vulnerable and without viable options.

Promising Early Results

Lundbeck's recent data, which will be presented during the AES congress, reflect enthusiastic outcomes from the Phase 1b/2a PACIFIC Trial and subsequent Open-Label Extension (OLE). The results reveal that a notable number of patients experienced a reduction in seizure occurrences, which were effectively maintained throughout a one-year observation period. Notably, these responses appeared consistent across the various DEE subtypes. "The evidence for bexicaserin is compelling, suggesting that reductions in seizures can be sustained and beneficial across diverse DEE syndromes," said Johan Luthman, EVP and Head of Research Development at Lundbeck.

A Closer Look at the PACIFIC Trial

During the PACIFIC trial, which involved a double-blind, placebo-controlled setup, bexicaserin was well tolerated with minimal significant safety concerns reported. Some adverse events included an ankle fracture and increased seizures, but overall, the data suggest that patients handled the treatment well. In fact, during the titration period, a mere 16.3% of participants discontinued due to side effects, reducing to 4.7% throughout the maintenance phase. Lundbeck's presentation will also include two-year follow-up results that reinforce the long-term efficacy of bexicaserin and detail its action mechanism and pharmacokinetics.

Implications and Future Research

The introduction of bexicaserin could revolutionize the treatment landscape for patients suffering from these debilitating conditions. Lundbeck's commitment to bringing innovative solutions to life reflects its relentless pursuit of advancements in neurology and psychiatry. The company is currently evaluating bexicaserin in a global Phase 3 clinical program, aptly named the DEEp Program. Recently, the FDA recognized the drug as a Breakthrough Therapy, underscoring its potential impact on patients aged two years and older. Furthermore, bexicaserin has received a similar designation in China, highlighting its international significance.

As the medical community gears up for the AES Annual Meeting, all eyes will be on Lundbeck and the groundbreaking presentations aimed at advancing treatment for childhood-onset epilepsies. Lundbeck’s research not only reinforces a commitment to addressing these rare yet impactful conditions but also emphasizes the hope for future therapeutic landscapes that can provide relief for patients who have faced very limited options thus far.