Announcement • Sep 03

H. Lundbeck A/S Highlights Mechanistic Insights and Clinical Data on Bexicaserin At the European Epilepsy Congress

H. Lundbeck A/S announced that preclinical data on the dual mode of action of bexicaserin will be featured in an oral presentation at the European Epilepsy Congress in Athens, Greece, 5-9 September, alongside additional presentations of clinical and preclinical data from the bexicaserin development program. The oral presentation will highlight mechanistic data supporting the scientific rationale of bexicaserin's dual mode of action as an investigational, oral, highly-selective superagonist of the 5-HT2c receptor. Through this mechanism, bexicaserin has been shown in preclinical studies to increase inhibitory and decrease excitatory neuronal activity. Preclinical data provide mechanistic insight into bexicaserin's dual mode of action, increasing inhibitory while decreasing excitatory neuronal activity, suggesting a broader antiseizure activity in preclinical models of focal, generalized motor and absence seizures across different etiologies. Bexicaserin is currently being evaluated in the global Phase III DEEp Program for the treatment of seizures associated with developmental and epileptic encephalopathies (DEEs). The preclinical data are relevant because many DEEs are associated with network hyperexcitability where an increase in excitation, decrease in inhibition, or both, can lead to seizures. In hippocampal brain tissue, bexicaserin increases inhibitory while decreasing excitatory neuronal activity, suggesting broad-spectrum antiseizure activity in preclinical models of different seizure types from various etiologies. The high affinity and selectivity of bexicaserin for 5-HT2C receptor supports the conclusion that these effects are mediated through this receptor. Bexicaserin is being evaluated in the global Phase III DEEp Program. The program includes DEEp OCEAN in children and adults living with DEEs, including Lennox-Gastaut syndrome, and DEEp SEA in children and adults living with Dravet syndrome. Bexicaserin is an investigational compound that is not approved for marketing by any regulatory authority worldwide. The efficacy and safety of bexicaserin have not been established. Data presentations at the European Epilepsy Congress include analyses of bexicaserin for the treatment of seizures in DEEs: response over time and responder rates in the Phase 1b/2a PACIFIC Trial OLE, interim analysis of an expanded access program for participants on treatment for up to 2 years, effects of bexicaserin on neural circuits in the DBA/1 mouse model of sudden unexpected death in epilepsy (SUDEP), and oral presentation on bexicaserin, a 5-hydroxytryptamine type 2C receptor superagonist, modulating inhibitory and excitatory neuronal function to exert antiseizure effects across etiologies and seizure types. Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no engagement of the 5-HT2B and 5-HT2A receptor subtypes, potentially minimizing the risk of cardiovascular toxicity. The most common TEAEs associated with bexicaserin in the PACIFIC trial were somnolence, decreased appetite, constipation, diarrhea, lethargy, tremor, urinary tract infection, fatigue, pyrexia, agitation, and hypertension. Bexicaserin acts via a dual mode of action, both increasing inhibitory and decreasing excitatory neuronal function, consistent with the reduction in seizures associated with DEEs arising from various etiologies. Bexicaserin is being evaluated in a global Phase III clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with DEEs for patients two years of age and older. Bexicaserin has also been granted Breakthrough Therapy Designation in China for the treatment of seizures associated with DEEs. DEEp OCEAN (NCT:06719141) is a Phase III interventional, randomized, double-blind, parallel-group, placebo-controlled trial evaluating bexicaserin in children and adults with DEEs, including LGS. The trial comprises a screening period of up to 35 days, followed by a 15-week treatment period consisting of a 3-week titration phase and a 12-week maintenance phase. Participants are randomized to receive either bexicaserin or placebo three times daily, with weight-based dosing used for pediatric participants. Following treatment, participants complete a taper period and safety follow-up or may transition into the 52-week DEEp open-label extension study (OLE). The aim of the trial is to evaluate the efficacy, safety, and tolerability of bexicaserin in reducing countable motor seizure frequency in patients with DEEs, including LGS. DEEp SEA (NCT:06660394) is a Phase III interventional, randomized, double-blind, parallel-group, placebo-controlled trial evaluating bexicaserin in children and adults with Dravet syndrome. The trial is currently enrolling participants globally. The trial comprises a screening period of up to 35 days, followed by a 15-week treatment period consisting of a 3-week titration phase and a 12-week maintenance phase. Participants are randomized to receive either bexicaserin or placebo three times daily, with weight-based dosing used for pediatric participants. Following treatment, participants complete a taper period and safety follow-up or may transition into the 52-week DEEp OLE. The aim of the trial is to evaluate the efficacy, safety, and tolerability of bexicaserin in reducing countable motor seizure frequency in patients with Dravet syndrome.

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