[News] New epilepsy drug (bexicaserin) getting good results in early trials

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Longboard drug bexicaserin, formerly known as LP352, was tested in a placebo-controlled Phase 1b/2a study whose main goal is measuring the change in seizure frequency. Preliminary results released Tuesday show the bexicaserin group achieved a median 53.3% reduction in seizure frequency in the 75-day treatment period compared to a 20.8% median decrease in seizure frequency in the placebo arm. With those results in hand, La Jolla, California-based Longboard said it is “rapidly moving forward” with plans to test its molecule in a global Phase 3 clinical trial.
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Longboard’s bexicaserin is a potential treatment for developmental and epileptic encephalopathies (DEEs) a group of severe epilepsies that begin to appear in early childhood. While DEEs may be treated with anti-epileptic drugs, these products have limited efficacy. However, Fintepla from UCB and Jazz Pharmaceuticals’ Epidiolex are newer epilepsy drugs that offer treatment alternatives for Dravet syndrome and Lennox-Gastaut syndrome, two forms of DEEs.

Bexicaserin is a small molecule designed to bind to and activate 5-HT2C, a receptor whose role includes modulating breathing, sleep-wake regulation, and seizure severity. UCB’s Fintepla is also a 5-HT2 agonist, but it has additional activity on closely related receptors, leading to adverse effects. This drug’s label has a black box warning that the product’s active ingredient is associated with the risk of valvular heart disease and pulmonary arterial hypertension. Epidiolex, whose active ingredient is derived from marijuana, has an unknown mechanism of action in epilepsy. The drug’s label has no black box warning.
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