Longboard Pharmaceuticals has commenced its Phase 3 DEEp OCEAN study, a global clinical trial assessing the efficacy of bexicaserin in treating seizures associated with Developmental and Epileptic Encephalopathies (DEEs). This pivotal study marks a significant step forward in addressing the unmet needs of individuals with DEEs, a group of severe neurological disorders characterized by early-onset, drug-resistant seizures and developmental delays.
The DEEp OCEAN study (LP352-301) is a double-blind, placebo-controlled trial designed to evaluate bexicaserin's effectiveness in reducing countable motor seizures in approximately 320 participants aged two to 65 years. The trial includes a 5-week screening period, a 3-week dose titration phase, and a 12-week maintenance period. Following the maintenance period, eligible participants can enroll in a 52-week open-label extension study (DEEp OLE Study, LP352-303).
Bexicaserin: A Novel Approach to DEE Treatment
Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist developed by Longboard Pharmaceuticals. It is designed to selectively activate the 5-HT2C receptor without impacting 5-HT2B and 5-HT2A receptor subtypes. The FDA has granted Breakthrough Therapy designation to bexicaserin for the treatment of seizures associated with DEEs in patients two years of age and older.
Addressing Unmet Needs in DEEs
DEEs represent a significant challenge in pediatric neurology, with many patients experiencing refractory seizures and developmental delays despite available treatments. The DEEp OCEAN study aims to provide a tailored clinical trial experience for individuals with underserved DEE syndromes.
Gabrielle Conecker, MPH, Executive Director & Co-Founder of Decoding Developmental Epilepsies, stated, "The majority of people living with DEEs lack access to innovative medications and have not had the opportunity to participate in clinical trials tailored to their condition. It’s encouraging to see strides being made in DEE research aimed at benefiting a broader population of patients who are suffering with refractory seizures and related health challenges."
Study Design and Objectives
The primary objective of the DEEp OCEAN study is to assess the efficacy of bexicaserin in reducing the frequency of countable motor seizures. Secondary objectives include evaluating the safety and tolerability of the drug. The study is part of the broader DEEp Program, which includes approximately 480 participants with various DEEs.
Chad Orevillo, Longboard’s Executive Vice President, Head of Operations, commented, "As the first pivotal trial of its kind to study DEEs broadly with the goal of achieving an indication for seizures associated with DEEs, DEEp OCEAN has the ability to address a crucial unmet need."
