KemPharm's Lead Prodrug Shows Favorable Safety Profile For Rare Sleeping Disorder

KemPharm's Lead Prodrug Shows Favorable Safety Profile For Rare Sleeping Disorder
  • KemPharm Inc KMPH announced topline data from its exploratory Phase 1 trial confirming the relative cardiovascular effects and pharmacokinetics of serdexmethylphenidate (SDX) compared to Ritalin (racemic methylphenidate), a commonly prescribed CNS stimulant. 
  • SDX, KemPharm's proprietary prodrug of d-methylphenidate (d-MPH), is the sole active pharmaceutical ingredient (API) in KP1077, a potential treatment for idiopathic hypersomnia (IH), a rare sleep disorder.
  • Based on the data, KemPharm believes the initial dosing strengths for the planned Phase 2 trial of KP1077 will be well-tolerated while providing higher overall exposures to d-MPH compared to other methylphenidate products that are often used off-label as a treatment for IH. 
  • KemPharm expects to initiate a Phase 2 trial of KP1077 in patients with IH before year-end 2022 and the second trial in patients with narcolepsy in 2023.
  • Initial results from the Phase 1 cardiovascular safety trial of SDX demonstrated the potential for 'higher dose' formulations of SDX to be safe and well-tolerated. 
  • Price Action: KMPH shares are up 6.61% at $6.16 on the last check Wednesday.

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