KMPH - KemPharm says trial data shows prodrug SDX could potentially treat sleep disorders

KemPharm (NASDAQ:KMPH) said full data from Phase 1 trial showed higher doses of serdexmethylphenidate (SDX) were generally well-tolerated and produced targeted pharmacodynamic effects, that may benefit to treat idiopathic hypersomnia and other sleep disorders. SDX is the active pharmaceutical ingredient in the company's therapy KP1077, which is being developed to treat idiopathic hypersomnia (IH). The company said the full data set affirmed that 240 mg and 360 mg doses of SDX were well-tolerated and produced d-methylphenidate exposure that appeared to increase proportionally with dose. KMPH said study participants reported increased wakefulness, alertness, hypervigilance, and insomnia effects, which suggests that SDX produced targeted pharmacodynamic effects. "The full data set from the Phase 1 clinical trial of ‘higher-dose’ SDX affirms our decision to select KP1077 as a treatment for IH as our lead development candidate and informs further development of SDX in related disorders," said KemPharm CEO, Travis Mickle. The company expects to file an Investigational

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KemPharm says trial data shows prodrug SDX could potentially treat sleep disorders