Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH) has announced the initiation of a Phase 3 global clinical trial, named DEEp SEA, to assess the efficacy and safety of bexicaserin in individuals aged 2 to 65 years with Dravet syndrome. This trial marks a significant step in the development of bexicaserin, a selective 5-HT2C receptor superagonist, as a potential treatment for seizures associated with developmental and epileptic encephalopathies (DEEs).
Bexicaserin's Regulatory Milestones
Bexicaserin has achieved several regulatory milestones, including Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for the treatment of Dravet syndrome. Additionally, the European Medicines Agency (EMA) Paediatric Committee (PDCO) issued a positive opinion of the Paediatric Investigation Plan for bexicaserin, supporting its development for children as young as two years old.
DEEp SEA Trial Details
The DEEp SEA study is a global Phase 3 clinical trial designed to evaluate the effectiveness of bexicaserin in a broad age range of Dravet syndrome patients. This trial will assess the drug's ability to reduce seizure frequency and improve overall clinical outcomes. The study includes participants aged 2-65 years, reflecting the need for effective treatments across the lifespan of individuals affected by Dravet syndrome.
PACIFIC Open-Label Extension Results
Interim analysis results from the PACIFIC open-label extension (OLE) study demonstrated a sustained and durable response in seizure reduction, along with a favorable safety and tolerability profile across a range of DEEs over approximately nine months of treatment with bexicaserin.
Strategic Acquisition by Lundbeck
In October, Longboard Pharmaceuticals announced an agreement for H. Lundbeck A/S (Lundbeck) to acquire Longboard in a strategic deal. This acquisition aims to leverage Lundbeck's expertise in neurological disorders to further advance the development and commercialization of bexicaserin and other pipeline assets.
Financial Position
As of September 30, 2024, Longboard's cash, cash equivalents, and short-term investments totaled approximately $288.4 million. Research and development expenses for the third quarter of 2024 were $21.5 million, an increase of $11.0 million compared to the same period in 2023. This increase is primarily attributed to clinical trial and preclinical expenses related to bexicaserin.
