Lundbeck’s receptor superagonist designed to treat seizures associated with developmental and epileptic encephalopathies (DEEs) has seen a 61.2% reduction in total seizures in a Phase Ib/IIa trial.
Interim analysis from the open-label extension (OLE) part of the Pacific trial (NCT05364021) examining bexicaserin, an oral 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, in patients who had previously been on placebo has seen the therapy able to elicit a 57.3% reduction in countable motor seizures and 61.2% reduction in total seizures in patients who had been switched from placebo. This was consistent with results in non-treatment naive patients after six months.
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At the same time, more than half of patients treated with bexicaserin experienced a more than 50% reduction from baseline in countable motor seizures. The OLE portion of the trial included patients who had successfully progressed through the Pacific trial, which was designed to evaluate the long-term safety tolerability and efficacy of bexicaserin across 52 weeks.
Johan Luthman, head of R&D at Lundbeck, said: “DEEs can be caused by a range of acquired, syndromal, and genetic etiologies, with more than 900 genes implicated. However, only a few subtypes currently have approved therapies, leaving many patients in need.
“The DEE-inclusive Pacific trial and six-month open-label extension data indicates that bexicaserin may be able to help address this unmet need across multiple DEE types, and highlights Lundbeck’s expanding commitment to the neuro-rare space.”
The Pacific trial recruited 52 patients from 34 sites across the US and Australia with DEE conditions who were on a stable regimen of one to four concomitant antiseizure medications. DEEs are a group of severe epilepsies including Dravet syndrome, Lennox-Gastaut syndrome and Landau-Kleffner syndrome.
Results from the Pacific trial are set to be read out as part of an oral presentation at the American Academy of Neurology (AAN) Annual Meeting on 7 April.
The company is also examining bexicaserin in its Phase III clinical programme, known as the DEEp Programme, including the DEEp Ocean study that aims to assess the efficacy of the drug by monitoring countable motor seizures in nearly 320 patients aged between two and 65 years.
Bexicaserin was acquired by Lundbeck as part of a $2.6bn buyout of Longboard Pharmaceuticals in December 2024.
Research by GlobalData estimates that by the end of 2029, bexicaserin could bring in as much as $52m for the company, with that figure rising to $192m by the end of 2031.
GlobalData is the parent company of Clinical Trials Arena. Elsewhere in the world of epilepsy therapies, Neurona will soon be initiating a Phase III trial of its gene therapy for drug-resistant epilepsy after raising $102m in a funding round.
