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) - Seite 2

Summary of Safety Data:

Bexicaserin exhibited favorable safety and tolerability results. Most participants (85.7%) in the bexicaserin treated group (n=35) that started the maintenance period tolerated the highest dose (12 mg). The most common adverse events (AEs) observed were somnolence, decreased appetite, constipation, diarrhea and lethargy. There were 3 participants that reported a serious adverse event (SAE) (ankle fracture, constipation, increased seizures) and no deaths were reported in the study. Overall, 9 participants in the bexicaserin group discontinued due to an AE. Of note, 2 of these participants discontinued during the maintenance period (7 participants discontinued during the titration period). No participants in the placebo group discontinued or experienced an SAE.

100% of the participants who completed the PACIFIC Study elected to enroll in the ongoing 52-week open-label extension study.

Additional data from the PACIFIC Study are intended to be presented at future medical meetings.

“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 in DEEs. We are pleased to see such strong seizure reduction across a wide range of DEE syndromes with varying etiologies coupled with favorable safety and tolerability results,” stated Dr. Randall Kaye, Longboard’s Chief Medical Officer. “We would like to thank the entire DEE community, including study participants, their caregivers and advocacy groups, as well as the investigators, sites and coordinators for their participation and continued partnership as we advance into a Phase 3 program. This tremendous milestone brings us one step closer to improving the lives of those living with these devastating diseases and their families.”

“The remarkable results from the PACIFIC Study give hope to patients and their loved ones who are in dire need of research and novel therapies in these severe syndromes. A tremendous unmet need remains not only for those living with LGS, but for the many other DEE patients who have not received the attention they deserve, and I applaud this innovative and inclusive approach that is designed to get therapies quickly and safely to even more people,” said Tracy Dixon-Salazar, PhD, Executive Director of the LGS Foundation.