Longboard Pharmaceuticals has initiated a Phase 3 global clinical trial, named DEEp SEA, to evaluate bexicaserin (LP352) in patients with Dravet syndrome. This trial includes participants aged 2 to 65 years. Bexicaserin is an oral, centrally acting 5-HT2C superagonist being developed for the potential treatment of seizures associated with developmental and epileptic encephalopathies (DEEs).
The initiation of the DEEp SEA study marks a significant step in Longboard's clinical program for bexicaserin. Dravet syndrome is a rare, severe form of epilepsy that begins in infancy and is characterized by frequent, prolonged seizures. There is a high unmet need for more effective and better-tolerated treatments for this condition.
Bexicaserin's Clinical Progress
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 broad range of DEEs over approximately nine months of treatment. These results support the continued development of bexicaserin as a potential therapy for DEEs.
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation and Rare Pediatric Disease designation to bexicaserin for the treatment of Dravet syndrome. These designations provide incentives for the development of drugs that treat rare diseases, underscoring the potential impact of bexicaserin on this patient population.
Regulatory and Financial Highlights
The European Medicines Agency (EMA) Paediatric Committee (PDCO) issued a positive opinion on the Paediatric Investigation Plan for bexicaserin, supporting its development for children down to the age of 2 years. Longboard Pharmaceuticals reported cash, cash equivalents, and short-term investments of approximately $288.4 million as of September 30, 2024.
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 related to clinical trial and preclinical expenses for bexicaserin.
Acquisition by Lundbeck
In October, Longboard announced an agreement for H. Lundbeck A/S to acquire Longboard in a strategic deal. This acquisition is poised to bolster the development and commercialization of bexicaserin, leveraging Lundbeck's expertise in neurological disorders.
