Positive Results from Pacific Trial

As announced in December 2024, Longboard Pharmaceuticals was acquired by Lundbeck. Longboard developed bexicaserin and conducted the Phase II program, the PACIFIC trial.

PACIFIC open-label extension study results: The PACIFIC OLE study is a 52-week Phase II, open-label, long-term safety study of bexicaserin in participants with a range of DEEs including Dravet syndrome (n=3), Lennox-Gastaut syndrome (n=20) and DEE Other (n=18), who completed the PACIFIC trial (n=41). The PACIFIC OLE study objectives are to investigate the safety and tolerability of multiple doses of bexicaserin in participants with DEEs, and to analyze the effect of bexicaserin on the frequency of observed countable motor seizures and other seizure types. The analysis of the OLE was conducted when participants reached the approximate 12-month point in the OLE study. The full results are expected to be presented at an upcoming medical conference in 2025.
 Summary of OLE efficacy results: The median change in countable motor seizure frequency for participants in the OLE study over an approximate 12-month treatment period was a decrease of 59.3% (n=40) from their baseline entering the PACIFIC OLE study. The median change in countable motor seizure frequency from baseline for: i. participants randomized to the bexicaserin-treated group in the PACIFIC trial that continued into the 12 month OLE was a decrease of 60.4% (n=31) ii. participants randomized to the placebo group in the PACIFIC trial that transitioned to bexicaserin in the OLE was a decrease of 58.2% (n=9) at 12 months.
 Summary of safety and tolerability results; 100% of PACIFIC trial completers elected to enroll in the OLE with 92.7% (38 out of 41) remaining throughout the 12-month open-label period.

Favorable safety and tolerability results were observed in this study. The most common treatment emergent AEs in the overall group (n=41) occurring in >5% of patients for the full 12-month OLE study were upper respiratory tract infections, seizures, COVID-19, decreased appetite, lethargy, pyrexia, gait disturbance, gastroenteritis viral, pneumonia, sinusitis, vomiting, weight decreased and rash.  One participant discontinued due to the adverse event (AE) of lethargy, one participant discontinued by withdrawal of consent and one participant discontinued due to other (relocation).