Longboard Pharmaceuticals has commenced the international Phase III DEEp SEA Study of its investigational asset bexicaserin (LP352) for treating seizures in Dravet syndrome patients.
The placebo-controlled, double-blind trial will enrol approximately 160 subjects between the ages of two and 65 years.
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It aims to evaluate the efficacy of bexicaserin by tracking countable motor seizures with safety and tolerability as its key secondary goal.
After five-week screening and baseline assessments, trial subjects will undergo a three-week dose titration, followed by a 12-week maintenance period on the highest tolerated dose.
Eligible participants can enrol in the 52-week DEEp Open-Label Extension (DEEp OLE Study LP352-303) after the maintenance phase.
The DEEp SEA Study is part of the larger DEEp programme, involving about 80 sites across the globe and enrolling nearly 480 participants with various developmental and epileptic encephalopathies (DEEs).
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By GlobalDataAn oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, bexicaserin has no effects on the 5-HT2B and 5-HT2A receptor subtypes.
Previously the drug received breakthrough therapy designation from the US FDA to treat seizures in DEEs for patients aged two years and older.
Longboard Pharmaceuticals head of Operations and executive vice-president Chad Orevillo said: “We are thrilled to announce the initiation of our global Phase III DEEp programme with our first sites activated and multiple additional sites primed for activation within the next couple of weeks for our DEEp SEA Study in Dravet syndrome. DEEp SEA is the first of two trials within the DEEp programme.
“I am extremely proud of the team for rapidly progressing from Phase II data to Phase III initiation further underscoring our commitment to the execution, efficiency and enrolment of our DEEp programme. We look forward to working with the healthcare professionals, patients and families on this important research programme.”
Recently, the company 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 DEEs.
