Danish pharmaceutical company H. Lundbeck A/S (CPH:HLUN-A) on Thursday announced positive results from the 12-month open-label extension of the Phase 1b/2a PACIFIC trial evaluating bexicaserin in participants aged 12-65 with Developmental and Epileptic Encephalopathies (DEEs).

Bexicaserin achieved an overall median seizure reduction of 59.3% in countable motor seizures over a 12-month open-label extension (OLE) treatment period. It demonstrated favourable safety and tolerability, with most participants completing the full 12 months OLE period.

The PACIFIC OLE study is a 52-week Phase 2, 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). Objectives are to investigate the safety and tolerability of multiple doses of bexicaserin in participants with DEEs, and to analyse 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. Full results are expected to be presented at an upcoming medical conference in 2025.

Johan Luthman, EVP and head of Research & Development at Lundbeck, said: "We are very pleased to observe a longer-term sustainable response, along with a favourable safety and tolerability profile over a 12-month period. These results further reinforce our confidence in bexicaserin's unique and potentially best-in-class profile. Considering the significant unmet needs of patients with DEEs, we are encouraged by the long-term sustainability of bexicaserin treatment."