Longboard Pharmaceuticals has announced the initiation of the Phase III DEEp OCEAN study, a global, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of bexicaserin in treating seizures associated with developmental and epileptic encephalopathies (DEEs). This trial marks a significant step forward in addressing a critical unmet need for patients with DEEs, a group of severe neurological disorders characterized by early-onset, drug-resistant seizures and developmental delays.
The DEEp OCEAN study aims to enroll approximately 320 participants aged between two and 65 years. The primary objective is to evaluate the efficacy of bexicaserin by monitoring countable motor seizures. Secondary objectives include assessing the tolerability and safety of the drug.
Trial Design and Methodology
Participants will undergo a five-week screening period followed by baseline assessments. The treatment phase includes a three-week dose titration period, during which the dose of bexicaserin is gradually increased to the highest tolerated level. This is followed by a 12-week maintenance period on the optimized dose. Following the maintenance period, eligible participants will have the option to enroll in a 52-week DEEp open-label extension study to further evaluate the long-term safety and efficacy of bexicaserin.
Bexicaserin: A Novel Therapeutic Approach
Bexicaserin is an investigational oral drug and a selective 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist. Notably, bexicaserin has demonstrated no significant impact on 5-HT2B and 5-HT2A receptor subtypes, potentially reducing the risk of off-target effects. The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to bexicaserin for the treatment of seizures associated with DEEs, underscoring the urgent need for new therapies in this patient population.
Addressing Unmet Needs in DEEs
DEEs represent a heterogeneous group of severe epilepsies that typically manifest in early childhood. These conditions are often characterized by frequent, drug-resistant seizures, significant developmental delays, and cognitive impairment. Current treatment options for DEEs are limited, and many patients continue to experience uncontrolled seizures despite multiple antiepileptic medications. The DEEp OCEAN study represents the first pivotal trial to study DEEs broadly, with the goal of achieving an indication for seizures associated with DEEs.
Management Perspective
Chad Orevillo, Longboard Pharmaceuticals' operations head and executive vice-president, stated, “The initiation of our second global Phase III clinical trial, DEEp OCEAN in DEEs, is a significant milestone for Longboard and the entire DEE community...DEEp OCEAN has the ability to address a crucial unmet need.”
This Phase III study is part of the broader DEEp Programme, which aims to enroll approximately 480 participants with various forms of DEEs.
