Positive PACIFIC Study Results for Bexicaserin in DEEs

Longboard Pharmaceuticals, a company in the clinical stage of development, has reported promising results from its PACIFIC Study, which evaluated the efficacy and safety of bexicaserin (LP352), a novel 5-HT2C receptor superagonist, in treating seizures associated with Developmental and Epileptic Encephalopathies (DEEs). The study involved 52 participants aged 12 to 65, diagnosed with DEEs, including Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), and other related conditions. The participants were treated with varying doses of bexicaserin or a placebo over a period that included a screening phase, dose titration, and a 60-day maintenance phase.

The study's efficacy data indicated that bexicaserin significantly reduced the frequency of countable motor seizures by a median of 53.3% compared to a 20.8% reduction in the placebo group. Specifically, the drug achieved a median seizure reduction of 72.1% in DS, 48.1% in LGS, and 61.2% in other DEEs. These reductions translate to a placebo-adjusted seizure frequency decrease of 32.5% overall, and 27.3% and 28.6% for LGS and other DEEs, respectively.

In terms of safety, bexicaserin demonstrated favorable tolerability, with the majority of participants (85.7%) able to tolerate the highest dose of 12 mg. Common adverse events included somnolence, decreased appetite, constipation, diarrhea, and lethargy. Serious adverse events were reported in three participants, and no deaths occurred during the study. Notably, all participants who completed the PACIFIC Study chose to enroll in a subsequent 52-week open-label extension study.

Dr. Randall Kaye, Longboard’s Chief Medical Officer, expressed enthusiasm for the results, stating that bexicaserin has the potential to become a best-in-class product and redefine the standard of care for DEEs. The company is now preparing for a global Phase 3 program and plans to present more data from the PACIFIC Study at upcoming medical meetings.

The PACIFIC Study's design and results have been lauded by healthcare professionals and patient advocacy groups for addressing a significant unmet need in the treatment of severe neurological conditions. The study's principal investigator, Dennis Dlugos, MD, highlighted the importance of developing treatments with fewer side effects and less burden for patients with highly refractory seizures.

Longboard Pharmaceuticals is advancing its product candidate bexicaserin into a global Phase 3 program, building on the positive outcomes of the PACIFIC Study. The company is also evaluating LP659, another drug in development for potential treatment of rare neuroinflammatory conditions, and has initiated a Phase 1 clinical trial for this compound.

The positive results from the PACIFIC Study are a significant milestone for Longboard Pharmaceuticals, bringing hope to patients and their families affected by DEEs and showcasing the company's commitment to developing innovative treatments for neurological diseases.