Deal to acquire Longboard Pharmaceuticals gives access to Bexicaserin for Dravet Syndrome
October 14 2024: H. Lundbeck A/S and Longboard Pharmaceuticals, Inc have announced an agreement for Lundbeck to acquire Longboard. Longboard is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases.
Through the acquisition of Longboard, Lundbeck gains access to bexicaserin, a novel 5-HT2C agonist in development for the treatment of seizures associated with DEEs, including Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies. This aligns with Lundbeck’s expertise in delivering innovative treatments and re-establishes scientific and commercial leadership in rare epilepsies.
Bexicaserin has entered a global phase III trial (DEEp SEA Study) evaluating bexicaserin for the treatment of seizures associated with Dravet syndrome in participants two years of age and older. The DEEp SEA Study is part of a broader DEEp Programme (DEEp SEA, DEEp OCEAN and DEEp OLE) which is planned to take place across ~80 sites globally and include ~480 participants with a range of DEEs. Bexicaserin has received Breakthrough Therapy Designation (BTD) from the U.S. FDA and is set to become a cornerstone of Lundbeck’s new neuro-rare disease franchise. Recent nine-month open-label data further supports the de-risked nature of its 5-HT2C mode-of-action, highlighting its superior target product profile.
About the DEEp SEA Study
The DEEp SEA Study (LP352-302) is a global phase III double-blind, placebo-controlled clinical trial to evaluate the efficacy of bexicaserin in Dravet syndrome as assessed by countable motor seizures in ~160 participants between the ages of two and 65 years old. An important secondary objective is to evaluate the safety and tolerability of bexicaserin. Following a 5-week screening period and baseline evaluations, study participants initiate dose titration over a 3-week period and subsequently continue on the highest tolerated dose throughout the maintenance period of 12-weeks. Following the maintenance period, eligible participants will be given the opportunity to enroll in the 52-week DEEp Open-Label Extension (DEEp OLE Study LP352-303). The phase III DEEp SEA Study is part of the broader DEEp Program which will take place across ~80 sites globally and include ~480 participants with a range of Developmental and Epileptic Encephalopathies (DEEs).
About Developmental and Epileptic Encephalopathies (DEEs)
Epilepsy is the third leading contributor to the global burden of neurological disorders and affects 65 million people worldwide. DEEs are a group of severe early-childhood onset epilepsies characterized by refractory seizures and developmental delay and/or regression. These diseases are often progressive and commonly show resistance to treatment. DEEs encompass a diverse range of over 25 syndromes, of which only four currently have FDA-approved therapies with partial treatment responses. Consequently, there is a remaining significant unmet need to find therapies that efficiently act across the DEE spectra. Some common epilepsy syndromes that are DEEs include:
- Dravet syndrome
- Lennox-Gastaut syndrome
- Tuberous sclerosis complex
- CDKL5 deficiency disorder
- Early infantile epileptic encephalopathy, including Ohtahara syndrome and early myoclonic encephalopathy
- Infantile epileptic spasms syndrome, including West syndrome
- Febrile infection-related epilepsy syndrome
- Epilepsy of infancy with migrating focal seizures
- Epilepsy with myoclonic-atonic seizures, otherwise known as myoclonic-atonic epilepsy (MAE) or Doose syndrome.
- Landau-Kleffner syndrome
- Developmental and epileptic encephalopathy with spike and wave activation in sleep (DEE-SWAS)
