Longboard Begins Phase 3 DEEp OCEAN Study on Bexicaserin for DEEs

Longboard Pharmaceuticals, Inc., based in LA JOLLA, Calif., has announced the commencement of its global Phase 3 DEEp OCEAN Study to evaluate its investigational drug, bexicaserin, for treating seizures in individuals with Developmental and Epileptic Encephalopathies (DEEs). This significant milestone marks an important step towards addressing a critical unmet need in the DEE community.

Chad Orevillo, Executive Vice President and Head of Operations at Longboard, highlighted the importance of the DEEp OCEAN trial. He emphasized that it is the first pivotal study of its kind to broadly examine DEEs with the aim of securing an indication for seizures associated with these conditions. This trial represents a beacon of hope for those living with underserved syndromes, reflecting the community's strong sense of urgency and enthusiasm.

Gabrielle Conecker, MPH, Executive Director & Co-Founder of Decoding Developmental Epilepsies, expressed her excitement about the potential impact of the DEEp OCEAN trial on the DEE community. She noted that most individuals with DEEs have limited access to innovative medications and clinical trials tailored to their condition. The advancements in DEE research are encouraging, as they aim to benefit a wider population of patients suffering from refractory seizures and related health challenges. Conecker also praised the movement towards greater equity and access for underserved patients and their families in clinical research.

The DEEp OCEAN Study, officially known as LP352-301, is a global Phase 3 double-blind, placebo-controlled clinical trial. It aims to evaluate the efficacy of bexicaserin in treating DEEs by assessing countable motor seizures in approximately 320 participants aged two to 65 years. An important secondary objective of the study is to evaluate the safety and tolerability of bexicaserin. Study participants will undergo a 5-week screening period followed by baseline evaluations. They will then initiate dose titration over a 3-week period, continuing on the highest tolerated dose throughout a 12-week maintenance period. After the maintenance period, eligible participants can enroll in the 52-week DEEp Open-Label Extension (DEEp OLE Study, LP352-303). The Phase 3 DEEp OCEAN Study is part of the broader DEEp Program, which includes around 480 participants with various Developmental and Epileptic Encephalopathies.

Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to developing transformative medicines for neurological diseases. The company focuses on advancing centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs). Their small molecule product candidates are based on over two decades of GPCR research.

Bexicaserin (LP352), an oral and centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, is the centerpiece of Longboard's global Phase 3 clinical program, the DEEp Program. Notably, bexicaserin has no observed impact on the 5-HT2B and 5-HT2A receptor subtypes. The FDA has granted Breakthrough Therapy designation to bexicaserin for treating seizures associated with DEEs in patients aged two years and older. It is important to note that bexicaserin is still an investigational compound and has not yet been approved for marketing by the FDA or any other regulatory authority.