Scilex (SCLX) Bio announced ongoing Phase 2 trial for obesity currently enrolling with U.S. patient cohort to be added in 2025 and positive topline results from the recently completed Phase 1 trials for oral KDS2010, a novel oral tablet small molecule agent. The ongoing obesity Phase 2 trial is a randomized, double-blind, placebo-controlled, dose finding, clinical trial to evaluate the safety and efficacy of KDS2010 in approximately 75 overweight or obese patients currently enrolling in South Korea with a cohort in U.S. to be added in 2025. KDS2010 has shown promising preclinical results with a novel mechanism of blocking MAO-B-dependent aberrant GABA production in reactive astrocytes and eliminates neuronal inhibition in Lateral Hypothalamic Area, stimulating metabolism and energy expenditure without affecting appetite. KDS2010 pharmacokinetics, lack of food effect, safety and dose selection have been characterized in Single Ascending Dose and Multiple Ascending Dose Phase 1 clinical trials with 88 healthy young adults and elderly subjects, demonstrating favorable safety and tolerability and adequate pharmacokinetics for once-daily dosing
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