Lundbeck hits recruitment milestone in Phase III Dravet syndrome trial

The completion of enrollment for the DEEp SEA trial marks a significant advance for Lundbeck’s broader clinical program. More than 100 participants, ranging from two to 65 years of age, are now set to undergo the 15-week evaluation period. The trial utilizes a double-blind, placebo-controlled design to measure the efficacy and safety of bexicaserin, a highly selective 5-HT2C receptor superagonist. Participants who complete the primary study may transition into a 52-week open-label extension to provide further long-term data.

This trial represents one of two pivotal studies currently assessing the drug. The sister program, DEEp OCEAN, which focuses on various developmental and epileptic encephalopathies excluding Dravet syndrome, finished its own randomization phase this past July. Because bexicaserin remains an investigational compound, it is not yet approved by any regulatory authority, though it has already secured Breakthrough Therapy designation from the FDA and in China. Tarek Samad, Lundbeck’s head of research and development, noted that the milestone underscores the collective effort of global investigators and families involved in tackling these complex neurological conditions.