• DEEp OCEAN is a global trial designed to evaluate the investigational molecule bexicaserin for the treatment of seizures associated with DEEs, a diverse group of childhood-onset epilepsies¹
• Broadest pivotal trial to date, enrolling patients with a wide range of DEE syndromes, the majority of which have limited treatment options where significant unmet need exists¹
• Headline results are expected at the end of Q4 2026 or Q1 2027
• In the DEEp SEA trial for Dravet syndrome, the second pivotal study within the DEEp clinical program, recruitment is progressing well with expected completion of randomization in the next few months

-H. Lundbeck A/S (Lundbeck) announced that the last patient has been randomized in DEEp OCEAN (NCT06719141), a global Phase III clinical trial evaluating the efficacy, safety and tolerability of bexicaserin for the treatment of seizures in children and adults living with developmental and epileptic encephalopathies (DEEs).

DEEs are a group of severe, childhood-onset epilepsies characterized by frequent seizures, developmental impairment, and substantial unmet medical need.¹ DEEs are a highly heterogeneous group of syndromes arising from a wide range of underlying etiologies.¹

Clinical development has historically focused on a limited number of individual DEE syndromes, such as Dravet syndrome (DS), Lennox–Gastaut Syndrome (LGS). There are currently no antiseizure medications (ASMs) approved across all DEE subtypes, leaving many patients without suitable treatment options.² The DEEp OCEAN trial was designed with the intention of addressing this gap.

"The DEEp OCEAN trial represents a comprehensive pivotal program in DEEs, with the most diverse DEE population studied to date," said Professor Ingrid Scheffer, lead investigator of the DEEp OCEAN trial. "By including a broad range of DEE syndromes and more than 60 different genetic DEEs, this study is designed to reflect the real-world heterogeneity of these devastating conditions."

The DEEp OCEAN trial will evaluate the safety, tolerability and efficacy of bexicaserin on countable motor seizures in people living with DEEs. The placebo-controlled, randomized multicenter trial enrolled over 350 participants aged two to 65 years and will be succeeded by an open-label extension for eligible participants.

The breadth of DEEp OCEAN positions Lundbeck to generate meaningful insights, not only into seizure control, but also into the potential best-in-class benefit-risk profile of bexicaserin across diverse DEE populations.

Bexicaserin is an oral, highly selective superagonist of the 5-HT2C receptor, a serotonin receptor subtype involved in seizure modulation. Acting via a dual mode of action, bexicaserin increases both inhibitory neuron activity while decreasing excitatory neuron function. This is consistent with the observed reduction in multiple seizure types across a broad range of DEE syndromes with various etiologies in the Phase IIa PACIFIC trial.

"The completion of randomization in DEEp OCEAN is an important milestone for the bexicaserin pivotal program, made possible by the commitment of patients, families, investigators, and advocacy communities. We look forward to headline results by the end of 2026 or early 2027," said Johan Luthman, Executive Vice President and Head of Research and Development at Lundbeck. "Additionally, we remain equally committed to the DEEp SEA trial in Dravet syndrome where we are seeing good progress in recruitment of patients and according to plan. We expect to close randomization within a few months."

Bexicaserin has received Breakthrough Therapy Designation in the U.S. and China for the treatment of seizures associated with DEEs. With randomization now complete, the multicenter DEEp OCEAN trial will continue as planned, with participants progressing through the double-blind treatment period followed by the optional open-label extension.