Positive PACIFIC Study Results for Bexicaserin in DEE Treatment

Longboard Pharmaceuticals, a company in the clinical stage of biopharmaceutical development, has reported promising results from its latest study on a new medication for neurological disorders. The drug, bexicaserin, has shown significant potential in reducing seizures associated with Developmental and Epileptic Encephalopathies (DEEs), a group of conditions characterized by severe epilepsy and developmental delays.

The PACIFIC Study, which was a double-blind, placebo-controlled trial, involved 52 participants aged between 12 and 65 years. The study was conducted across 34 sites in the United States and Australia. Participants were given varying doses of bexicaserin—6 mg, 9 mg, and 12 mg—three times a day, compared to a placebo. The diagnoses of the participants included Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), and other DEEs.

The results were striking, with bexicaserin reducing the median countable motor seizures by 53.3% compared to a 20.8% reduction in the placebo group. When broken down by syndrome, bexicaserin reduced seizures by 72.1% in DS, 48.1% in LGS, and 61.2% in other DEEs. This suggests a substantial reduction in seizure frequency across different types of DEEs.

Safety and tolerability were also favorable, with the majority of participants tolerating the highest dose of bexicaserin. Common side effects included drowsiness, decreased appetite, constipation, diarrhea, and lethargy. Serious adverse events were reported in three participants, but no fatalities occurred during the study. Notably, all participants who completed the PACIFIC Study chose to enroll in a 52-week open-label extension study.

Dr. Randall Kaye, Chief Medical Officer at Longboard Pharmaceuticals, expressed optimism about the results, stating that bexicaserin's unique profile could redefine treatment standards for DEEs. The company is now gearing up for a global Phase 3 program and plans to present more data from the PACIFIC Study at upcoming medical conferences.

The PACIFIC Study's innovative approach to clinical development has been praised for its inclusivity and potential to quickly and safely provide new treatment options for DEE patients. Tracy Dixon-Salazar, Executive Director of the LGS Foundation, applauded the study's design and its focus on addressing the significant unmet needs of DEE patients.

Dennis Dlugos, MD, a pediatric neurologist and Principal Investigator of the PACIFIC Study, highlighted the importance of the results for physicians seeking treatment options with fewer side effects and less burden for their patients. Kevin R. Lind, President and CEO of Longboard Pharmaceuticals, emphasized the study's groundbreaking design and the broad efficacy of bexicaserin as a foundation for building a world-class epilepsy franchise.

Longboard Pharmaceuticals is committed to advancing its portfolio of product candidates targeting specific G protein-coupled receptors (GPCRs). The company's focus on highly selective medicines for neurological diseases is based on extensive research into GPCRs. In addition to bexicaserin, Longboard is also developing LP659, a drug for potential treatment of rare neuroinflammatory conditions, with topline data from its Phase 1 clinical trial expected in the first half of 2024.

The company's commitment to improving the lives of those affected by neurological diseases and their families is evident in its ongoing research and development efforts. With the positive results from the PACIFIC Study, Longboard Pharmaceuticals is well-positioned to contribute significantly to the field of neurology and epilepsy treatment.