Lundbeck preps for key bexicaserin data around year-end

Lundbeck has completed patient randomisation in a pivotal trial of epilepsy candidate bexicaserin, one of its major growth hopes, and is anticipating results at the end of this year or in early 2027.

The neuroscience specialist added the oral, centrally acting serotonin 5-HT 2C receptor super-agonist to its pipeline when it acquired Longboard Pharmaceuticals for $2.6 billion in 2024, pointing to its blockbuster potential in seizures associated with rare forms of epilepsy known as developmental and epileptic encephalopathies (DEEs).

To date, some treatment advances have been seen in some DEEs, notably Dravet syndrome (DS) and Lennox–Gastaut syndrome (LGS), but most DEEs have no effective treatments, and patients often have to take multiple anti-seizure medicines (ASMs) to try to keep seizures under control, often with a high side-effect burden.

The international DEEp OCEAN study is testing bexicaserin in 350 patients with a wide range of DEE syndromes, most of which have limited treatment options, to see if the drug can improve on placebo in cutting the number of motor seizures.

It has recruited children and adults with LGS as well as other DEEs, such as tuberous sclerosis complex (TSC) and CDKL5 deficiency disorder (CDD), in the hope of supporting regulatory filings for bexicaserin as a drug that can be used more widely across different DEE types.

"The DEEp OCEAN trial represents a comprehensive pivotal program in DEEs, with the most diverse DEE population studied to date," said Prof Ingrid Scheffer of the Florey Institute of Neuroscience and Mental Health in Australia, who is the lead investigator of the study.

"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," she added.

Lundbeck is also running a second phase 3 trial – called DEEp SEA – specifically in DS, and said it expects to complete patient randomisation for that in the next few months.

If all goes as planned, Lundbeck expects bexicaserin to fuel its growth into the next decade. The acquisition of Longboard was its largest in recent years, overtaking its $1.95 billion takeover of migraine drug developer Alder BioPharma in 2019, which gave it intravenous migraine prevention therapy Vyepti (eptinezumab).

Bexicaserin, which has breakthrough designation in the US and China, is one of the assets added by Lundbeck in a concerted effort to rebuild its pipeline, after some clinical disappointments involving drugs like Lu AF35700 for resistant schizophrenia and a subcutaneous formulation of Vyepti.

Others include MSA treatment amlenetug, an anti-alpha-synuclein antibody that moved into late-stage development despite some mixed phase 2 data, anti-PACAP drug bocunebart for migraine prevention, and ACTH inhibitor asedebart for Cushing's disease and congenital adrenal hyperplasia (CAH).

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