Longboard Pharmaceuticals has revealed interim results from its 52-week open-label extension of the Phase II PACIFIC Study of bexicaserin in individuals aged 12-65 years with developmental and epileptic encephalopathies (DEEs).
The open-label, long-term safety study assessed bexicaserin in subjects with various DEEs including Dravet syndrome (n=3), Lennox-Gastaut syndrome (n=20) and DEE other (n=18), who had completed the initial PACIFIC Study.
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Safety and tolerability of varying doses of bexicaserin in subjects with DEEs as well as assessing bexicaserin’s impact on the frequency of observed countable motor seizures and other seizure types were the trial objectives.
The interim analysis, carried out approximately nine months into the study, showed a median decrease in countable motor seizure frequency of 57.7% across 40 participants.
The results were consistent regardless of the initial randomisation in the PACIFIC Study, with a 58.2% reduction in seizures for the bexicaserin-treated group and a 57.3% reduction for those who transitioned from placebo to bexicaserin in the OLE.
The study also noted a high retention rate, with 92.7% of participants choosing to continue with the open-label extension.
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By GlobalDataSafety and tolerability were also reported, with the majority of adverse events being non-severe and included upper respiratory tract infections, Covid-19, pneumonia, sinusitis, decreased appetite, pyrexia, and weight decrease.
Longboard chief medical officer Dr Randall Kaye said: “We are thrilled that bexicaserin is continuing to demonstrate a sustained, durable response in seizure reduction and a favourable safety and tolerability profile across a broad range of DEE patients. These data provide further support to bexicaserin’s potential to offer a highly differentiated and best-in-class profile.
“Given the tremendous unmet need in patients living with DEEs, we are committed to rapidly advancing the development of bexicaserin. We expect to provide a full analysis of participants with 12-month data early next year as they complete the OLE Study and transition to our Expanded Access Program.
“With Breakthrough Therapy designation granted, we remain on track to initiate our global Phase III programme for bexicaserin later this year.”
