KemPharm's Phase I Cardiovascular Safety Study Of Serdexmethylphenidate Yields Positive Results

(RTTNews) - Florida-based KemPharm Inc. (KMPH) has announced positive top-line data from an exploratory phase I trial evaluating the cardiovascular safety of its d-methylphenidate prodrug Serdexmethylphenidate.

The phase I trial compared the cardiovascular effects and pharmacokinetics of Serdexmethylphenidate against immediate-release and long-acting formulations of Novartis' Ritalin a commonly prescribed CNS stimulant.

Serdexmethylphenidate (SDX) administered at single doses of 80 mg and 200 mg was well-tolerated, according to the trial results. SDX is the sole active pharmaceutical ingredient in KemPharm's lead drug candidate KP1077, a potential treatment for idiopathic hypersomnia (IH), a rare sleep disorder.

KP1077 is expected to advance into a phase II trial in patients with idiopathic hypersomnia prior to year-end 2022 and a second trial in patients with narcolepsy in 2023.

Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm, said on Monday, "We are pleased with the initial results from the Phase 1 cardiovascular safety trial of SDX, which demonstrated the potential for 'higher dose' formulations of SDX to be safe and well-tolerated. These data add to our confidence that the planned doses for the upcoming Phase 2 trial of KP1077 in IH will provide higher exposures to d-MPH while avoiding the potential for greater cardiovascular safety risk as compared to current methylphenidate products being used off-label."