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Lundbeck to present eight new analyses on bexicaserin at AES 2025, reinforcing sustained seizure-reduction potential across DEEs
Lundbeck A/S (Lundbeck) announced that new pipeline data regarding bexicaserin (LP352), a novel investigational drug for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs), will be presented at the 2025 American Epilepsy Society Congress in Atlanta, USA (Dec 5 – 9). The comprehensive dataset includes a recent post-hoc analysis from Phase 1b/2a PACIFIC trial and Open-Label Extension (OLE) indicating patients with DEEs experienced an early response to bexicaserin which was sustained over the long-term.1
DEEs are a group of childhood onset epilepsies characterized by drug-resistant seizures and developmental and intellectual disabilities.2 In DEEs, excessive electrical activity in the brain results in seizures and cognitive impairments, leaving patients heavily dependent on caregivers.2,3 Currently, only a few types of DEEs have authorized antiseizure medications (ASMs), leaving most DEE patients vulnerable and without an approved treatment.3
“Most DEEs are resistant to conventional anti‑seizure medicines, leaving patients with very few options,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck. “The data for bexicaserin are compelling—indicating early seizure reductions that are sustained across diverse DEE syndromes. These results underscore its potential as a first‑in‑class treatment across this devastating range of epilepsies.”
The new analyses indicate that there were fewer countable motor seizures as early as two weeks following bexicaserin treatment initiation and that these reductions were maintained over a full year of open label observation. This observed response was consistent across DEE subtype.1
During the PACIFIC trial, bexicaserin was generally well tolerated with no significant safety concerns. Three participants in the bexicaserin group reported a serious adverse event (ankle fracture x 2, constipation, and increased seizures). Throughout the titration period, 16.3% of bexicaserin-treated patients discontinued due to an adverse event, while across the maintenance period, 4.7% of bexicaserin-treated participants discontinued due to an adverse event. No new safety concerns were observed during the open label extension period.
During the AES congress, Lundbeck will also showcase two-year follow-up results from the PACIFIC trial, further reinforcing bexicaserin’s durable and consistent effect across a broad range of DEEs, along with the drug’s mode of action, pharmacokinetics, and negligible drug-drug interaction.4-10
The eight presentations at AES 2025 demonstrate the breadth of Lundbeck’s R&D program and ongoing dedication to reducing the burden of these devastating rare childhood onset epilepsies.
Bexicaserin is an investigational compound that is not approved for marketing by any regulatory authority worldwide. The efficacy and safety of bexicaserin have not been established.
View Lundbeck’s scientific presentations at AES HERE.
