Longboard Pharmaceuticals Starts Phase 3 Study of Bexicaserin in Dravet Syndrome

Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company headquartered in La Jolla, California, has commenced its global Phase 3 DEEp SEA Study. This study will evaluate the efficacy of their investigational drug bexicaserin for treating seizures associated with Dravet syndrome in individuals aged two years and older.

Chad Orevillo, Executive Vice President and Head of Operations at Longboard, expressed enthusiasm over the launch of the global Phase 3 DEEp Program, noting that the first sites are already active, with more expected to follow shortly. Orevillo emphasized the team's rapid progression from Phase 2 data to Phase 3 initiation, showcasing the company's dedication to the execution and efficient enrollment of the DEEp Program. He looks forward to collaborating with healthcare professionals, patients, and families involved in this significant research endeavor.

Mary Anne Meskis, Founding Member and Executive Director of the Dravet Syndrome Foundation, praised Longboard's recent strides in Dravet syndrome research, including receiving Rare Pediatric Disease and Orphan Drug designations and now launching the DEEp SEA Study. She highlighted the considerable unmet need in Dravet and other rare epileptic conditions and expressed optimism over advancements in this medical field.

The DEEp SEA Study, designated LP352-302, is a global Phase 3 double-blind, placebo-controlled clinical trial aiming to assess the efficacy of bexicaserin in Dravet syndrome by tracking countable motor seizures in approximately 160 participants aged two to 65 years. A secondary objective of the study is to evaluate the safety and tolerability of bexicaserin. Following a five-week screening and baseline evaluation period, participants will begin dose titration over three weeks and then continue on the highest tolerated dose during a 12-week maintenance period. Those eligible after the maintenance period may join a 52-week DEEp Open-Label Extension (OLE) Study, designated LP352-303. The Phase 3 DEEp SEA Study is part of Longboard's broader DEEp Program, which will occur across roughly 80 global sites and include about 480 participants with various Developmental and Epileptic Encephalopathies (DEEs).

Longboard Pharmaceuticals is dedicated to developing innovative medicines for neurological diseases, leveraging over two decades of GPCR research. Bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, is currently being evaluated in the DEEp Program. The FDA has granted Breakthrough Therapy designation to bexicaserin for treating seizures related to DEEs in patients aged two years and older.

In addition to bexicaserin, Longboard is also investigating LP659, an oral, centrally acting sphingosine-1-phosphate (S1P) receptor modulator targeting subtypes 1 and 5. LP659 is being developed for potential treatment of rare neuroinflammatory conditions and has recently completed a Phase 1 single-ascending dose trial in healthy volunteers.

Both bexicaserin and LP659 remain investigational and have not received marketing approval from the FDA or any other regulatory body.