“We are honored that bexicaserin has been granted Breakthrough Therapy Designation, recognizing the potential of our innovative approach to advancing treatment in one of the most challenging areas of epilepsy,” says Johan Luthman, EVP and Head of Research & Development at Lundbeck. “Drawing on our expertise in neuroscience, and past experiences with epilepsy therapies, we are deeply committed driving the global Phase 3 clinical program forward. Obtaining BTD for the program in China supports us in bringing Bexicaserin to patients living with DEEs as quickly as possible.”

DEEs

DEEs are a heterogeneous group of severe, childhood-onset, rare epilepsies marked by drug‑resistant seizures and developmental stagnation or regression. Affecting more than 1 in 2,000 live births, DEEs carry a mortality rate of 17–50%. Survivors are often left with profound neurological disabilities, creating a heavy burden for families and society and underscoring the urgent need for new treatment options.

Bexicaserin

Bexicaserin (LP352) is a novel investigational, oral therapy that selectively targets the 5‑HT2C receptor while avoiding activity at the 5‑HT2B and 5‑HT2A subtypes, a profile designed to reduce cardiovascular risk. The medicine has also been granted BTD by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with DEEs.