KemPharm Inc KMPH completed its analysis of the full data set from its Phase 1 clinical trial of serdexmethylphenidate (SDX) delivered at doses higher than those previously studied.
- SDX, KemPharm's proprietary prodrug of d-methylphenidate (d-MPH), is the sole active pharmaceutical ingredient (API) in KP1077, under development for idiopathic hypersomnia (IH).
- The full data set built on the previously reported topline data affirmed that 240 mg and 360 mg doses of SDX were well-tolerated and produced d-MPH exposure that appeared to increase proportionally with dose.
- Mean d-MPH plasma concentrations gradually increased after SDX administration, reaching a broad peak from eight to twelve hours post-dose, followed by a shallow decline.
- Study participants reported increased wakefulness, alertness, hypervigilance, and insomnia effects.
- KemPharm anticipates filing an Investigational New Drug (IND) application for KP1077 as early as Q2 of 2022 and subsequently initiating a Phase 2 trial in patients with IH in 2H of 2022.
- Additionally, the Company expects to receive results from an additional trial to assess the relative cardiovascular safety of SDX vs. current stimulant treatments also in 2H of 2022.
- Price Action: KMPH shares are down 1.87% at $5.25 during the market session on the last check Monday.
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