Longboard Pharmaceuticals has commenced the Phase III DEEp OCEAN Study of its investigational oral drug bexicaserin for treating seizures linked to developmental and epileptic encephalopathies (DEEs) in participants aged two years and above.
The study aims to assess the efficacy of the drug by monitoring countable motor seizures in nearly 320 participants aged between two and 65 years.
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It is a global, double-blind, placebo-controlled clinical trial, with a secondary objective to evaluate the tolerability and safety of bexicaserin.
Participants will undergo a five-week screening period, followed by baseline assessments. The treatment phase includes a three-week dose titration period and a 12-week maintenance period on the highest tolerated dose.
After completing the maintenance period, participants who are eligible will have the option to join a 52-week DEEp open-label extension.
Longboard Pharmaceuticals operations head and executive vice-president Chad Orevillo said: “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.
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By GlobalData“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.”
This Phase III study is a part of the DEEp Programme, which encompasses approximately 480 participants with various forms of DEEs.
Bexicaserin, a 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, has shown to have no impact on 5-HT2B and 5-HT2A receptor subtypes.
The US Food and Drug Administration (FDA) granted breakthrough status for the drug for this indication.
Bexicaserin has not yet been approved for marketing by the FDA or any other regulators.
In September 2024, the company reported interim results from its 52-week open-label extension of the Phase II PACIFIC Study of bexicaserin in people aged 12-65 years with DEEs.
