The DEEp OCEAN study enrolled over 350 participants aged two to 65 years to test the efficacy, safety, and tolerability of bexicaserin. As a highly selective 5-HT2C receptor superagonist, the molecule employs a dual mechanism to increase inhibitory neuron activity while simultaneously suppressing excitatory function. This approach aims to address the real-world heterogeneity of conditions that have historically frustrated clinical development due to their wide range of etiologies.
Lundbeck Completes Patient Enrollment in Pivotal DEEp OCEAN Trial
Lundbeck has finalized randomization for the DEEp OCEAN Phase III clinical trial, a global study evaluating the investigational drug bexicaserin. The trial targets developmental and epileptic encephalopathies, a diverse group of severe childhood-onset epilepsies that currently lack comprehensive treatment options for many of the various underlying genetic syndromes.
Lead investigator Professor Ingrid Scheffer noted that the trial encompasses more than 60 different genetic DEEs, positioning it as the most diverse study of its kind to date. Following the completion of the double-blind treatment period, participants may transition into an open-label extension. Lundbeck anticipates releasing headline results between late 2026 and early 2027. Simultaneously, the company is progressing with its DEEp SEA trial focused on Dravet syndrome, with patient recruitment expected to conclude within the coming months.
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