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Lundbeck hits recruitment milestone for broad-spectrum epilepsy trial

Lundbeck has finalized patient randomization for DEEp OCEAN, a pivotal Phase III clinical trial testing the investigational molecule bexicaserin. The study targets a wide spectrum of developmental and epileptic encephalopathies, marking a significant step toward addressing a group of severe childhood-onset conditions that currently lack universal treatment options.

Lundbeck hits recruitment milestone for broad-spectrum epilepsy trial

The DEEp OCEAN trial is notable for its scale, enrolling more than 350 participants aged two to 65 across a diverse range of genetic syndromes. Unlike previous research that focused on isolated conditions like Dravet or Lennox–Gastaut syndromes, this program aims to capture the real-world heterogeneity of over 60 different genetic DEEs. Lead investigator Professor Ingrid Scheffer noted that the study’s design reflects the complexity of these conditions, providing a broad testing ground for the molecule's efficacy in reducing motor seizure frequency.

Bexicaserin functions as a highly selective superagonist of the 5-HT2C receptor, utilizing a dual mode of action to modulate neuronal activity. Given its Breakthrough Therapy Designation in both the U.S. and China, expectations for the trial are high. Lundbeck anticipates sharing headline results between the end of 2026 and early 2027. Meanwhile, the company continues to advance its parallel DEEp SEA trial, which focuses specifically on Dravet syndrome, with randomization expected to conclude in the coming months.

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