Positive data reported from phase 1b/2a study of oral superagonist for epileptic seizures

A clinical-stage biopharmaceutical company has announced positive topline data from a study evaluating a novel, oral 5-HT2C receptor superagonist for seizures associated with developmental and epileptic encephalopathies.

According to a release from Longboard Pharmaceuticals, 52 participants in the phase 1b/2a PACIFIC study with a diagnosis of developmental and epileptic encephalopathies (DEE) who were treated with bexicaserin three times per day experienced a median decrease in countable motor seizure frequency from baseline of 53.3% compared with 20.8% for those receiving placebo.

Bexicaserin also demonstrated favorable safety and tolerability results, as a majority of participants (85.7%) in the bexicaserin group that began the maintenance period tolerated the highest dose (12 mg). The most common recorded adverse events were somnolence, decreased appetite, constipation, diarrhea and lethargy. Three participants reported serious adverse events (ankle fracture, constipation, increased seizures), but no deaths were reported.

The company additionally revealed that 100% of the participants who completed the PACIFIC Study elected to enroll in the ongoing 52-week open-label extension.

“These exciting PACIFIC Study results underscore our belief that bexicaserin’s differentiated profile will translate into a clinically and commercially best-in-class product and has the potential to redefine the standard of care,” Randall Kaye, MD, Longboard’s chief medical officer, stated in the release. “This milestone brings us one step closer to improving the lives of those living with these devastating diseases and their families.”

Additional data from the PACIFIC study is expected to be presented at future medical meetings, Longboard said in the release.