Longboard Pharmaceuticals Announces Positive Topline Data from the PACIFIC Study, a Phase 1b/2a Clinical Trial, for Bexicaserin (LP352) in Participants with Developmental and Epileptic Encephalopathies (DEEs)

• Bexicaserin achieved a median seizure reduction of 53.3% in countable motor seizures compared to 20.8% in the placebo group across the DEE study population
• A median seizure reduction of 72.1% in Dravet Syndrome (DS), 48.1% in Lennox-Gastaut Syndrome (LGS) and 61.2% in DEE Other was achieved
• Favorable safety and tolerability results
• Longboard is rapidly moving forward with preparations for its global Phase 3 program
• Conference call and webcast to be held today at 8:30am ET

Excerpt from the Press Release:

LA JOLLA, Calif.–(BUSINESS WIRE)–Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced positive topline data from the PACIFIC Study evaluating bexicaserin (LP352), a potentially best-in-class and highly selective, oral, novel 5-HT2C receptor superagonist for seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs).

The PACIFIC Study Topline Results:

In the innovative PACIFIC Study, 52 participants ages 12-65 years old with a DEE diagnosis were enrolled at 34 study sites across the United States and Australia to evaluate the safety, tolerability, efficacy and pharmacokinetics of oral bexicaserin (6 mg, 9 mg and 12 mg) three times daily (TID) versus placebo. Participant DEE diagnoses included DS, LGS, and other qualifying DEEs (DEE Other). Following a 5-week screening period and baseline evaluations, study participants initiated a dose titration over a 15-day period and subsequently continued on the highest tolerated dose throughout the maintenance period of 60 days. Of the 52 participants enrolled in the study, 43 participants were randomized to bexicaserin (DS=4, LGS=24, DEE Other=15) and 9 to placebo (DS=0, LGS=5, DEE Other=4). The median number of countable motor seizures per 28-day period at baseline was 38.8 in the bexicaserin group compared to 20.8 in the placebo group. Participants were able to remain on a contemporary, stable polytherapy regimen of up to 4 anti-seizure medications (ASMs) throughout the study, with the most common ASMs being clobazam, cannabidiol, lamotrigine and levetiracetam.

Click the button below to read the entire Press Release:

Continue Reading The Press Release