KMPH - KemPharm posts Phase 1 data to support further studies for sleep disorder therapy

• KemPharm, Inc. ( NASDAQ: KMPH ), a company developing prodrug versions of FDA-approved drugs, announced Wednesday early results from a Phase 1 trial to support further studies for lead asset KP1077 in sleep-related disorders.
• The Phase 1 open-label trial involving 15 volunteers was designed to evaluate single doses of 80 mg and 200 mg of serdexmethylphenidate (SDX), a prodrug of d-methylphenidate (d-MPH) and the only active pharmaceutical ingredient (API) in KP1077.
• The investigators compared SDX's cardiovascular effects and pharmacokinetics against immediate-release and long-acting formulations of Ritalin (racemic methylphenidate), a commonly used CNS stimulant.
• Citing the topline data, KMPH said that the initial dosing levels it has selected for the Phase 2 trial for KP1077 would be well tolerated leading to higher exposure to d-MPH compared to existing methylphenidate products.
• Before the year-end, the company plans to start a mid-stage trial for KP1077 in idiopathic hypersomnia, a rare sleep disorder. Another study is expected to begin in 2023, targeting patients with narcolepsy.
• Read more on the upcoming catalysts for KMPH as outlined by the management in August.

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