The commitment to advancing the development of bexicaserin for patients with Developmental and Epileptic Encephalopathies (DEEs) is emphasized by Dr. Kaye. Further analysis of participants in the OLE Study and their transition to the Expanded Access Program is anticipated. An End of Phase 2 meeting is scheduled for the upcoming summer, aligning with plans to initiate a global Phase 3 program for bexicaserin later in the year.
The interim analysis of the PACIFIC OLE Study, a 52-week Phase 2 open-label study, included participants with various DEEs such as Dravet syndrome, Lennox-Gastaut syndrome, and DEE Other. The primary aim was to assess the safety and tolerability of bexicaserin and its impact on motor seizures. Results showed a median reduction of 56.1% in countable motor seizure frequency after approximately 6 months of treatment in the OLE Study.
Regarding safety and tolerability, the study demonstrated favorable outcomes with a high retention rate among participants. The most common treatment emergent adverse events included upper respiratory tract infections, COVID-19, pneumonia, sinusitis, seizures, and decreased appetite.
The PACIFIC Study, a Phase 1b/2a clinical trial, evaluated bexicaserin in participants with DEEs between the ages of 12 and 65 across multiple sites. Longboard Pharmaceuticals, a clinical-stage biopharmaceutical company, focuses on developing innovative medicines for neurological diseases. The company’s product candidates, including bexicaserin, aim to provide selective treatment for G protein-coupled receptors. Positive data from the PACIFIC Study has positioned bexicaserin for progression into a global Phase 3 program.
The forward-looking statements in this release highlight Longboard Pharmaceuticals’ commitment to its clinical and preclinical product candidates. Factors influencing the company’s progress include ongoing clinical trials, regulatory considerations, and market dynamics. Longboard Pharmaceuticals acknowledges potential challenges and uncertainties in its development and commercialization efforts, emphasizing its dedication to delivering effective treatment options for neurological conditions.
