Lundbeck to buy maker of Dravet syndrome treatment bexicaserin
Seizure treatment being developed for Dravet, other DEEs
Lundbeck agreed to acquire the company developing bexicaserin, an investigational treatment for seizures associated with Dravet syndrome and other developmental and epileptic encephalopathies (DEEs).
Lundbeck will buy Longboard Pharmaceuticals for $60 a share in cash, or a total of about $2.6 billion, the companies announced.
“Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available,” Charl van Zyl, Lundbeck’s president and CEO, said in a press release from the companies. “With this acquisition, we continue to execute on our focused innovator strategy, transforming the lives of patients suffering from severe brain disorders.”
Dravet syndrome is a form of epilepsy characterized by frequent and prolonged motor seizures, uncontrolled bursts of electrical activity in the brain that affect muscles. These seizures often start early in infancy and are usually difficult to control with available medications.
Bexicaserin is an oral therapy that works by binding and activating 5-HT2C, a receptor in the brain and spinal cord that binds serotonin, a chemical messenger needed for nerve cell communication. This is expected to ease the abnormal electrical activity in the brain that leads to seizures.
Clinical trials
The therapy’s efficacy, safety, and tolerability are being evaluated in the global Phase 3 DEEp SEA trial, which expects to enroll 160 people with Dravet and other DEEs, ages 2 to 65. Participants will receive either bexicaserin or a placebo for about three months, and may enroll in an extension study for one year after completing the trial.
In the Phase 1b/2a PACIFIC trial (NCT05364021), treatment with bexicaserin significantly reduced seizure frequency in children with Dravet syndrome and other DEEs, compared with a placebo. In the four participants with Dravet who were treated with bexicaserin, the median seizure frequency was reduced by 72.1%.
The treatment was generally well tolerated. The most common side effects were sleepiness or lack of energy, decreased appetite, constipation, and diarrhea.
In the trial’s one-year open-label extension (NCT05626634), treatment with bexicaserin maintained seizure frequency reduction after nine months of treatment.
“Longboard was founded to transform the lives of people living with devastating neurological conditions,” said Kevin R. Lind, the company’s president and CEO. The acquisition “will accelerate our vision to provide increased equity and access for underserved DEE patients with significant unmet medical needs,” he said.
Bexicaserin has received breakthrough therapy, orphan drug, and rare pediatric disease designations from the U.S. Food and Drug Administration. Those designations are aimed at accelerating the development and regulatory review of medications intended to treat serious or life-threatening conditions.
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