Summary: Zevra Therapeutics Inc., in its year-end financial and corporate update for 2023, highlighted the progress of KP1077 in treating idiopathic hypersomnia, citing promising Phase 2 study results. The company also announced plans to present new data from a Phase 1 study under the narcolepsy Investigational New Drug application, alongside final Phase 2 results of KP1077 in idiopathic hypersomnia, at the upcoming SLEEP 2024 conference.

Zevra Therapeutics Inc, focusing on rare disease treatments, reported solid progress in 2023, including promising results from the KP1077 phase 2 study for idiopathic hypersomnia, with plans to expand into narcolepsy, as part of its fourth-quarter and full-year 2023 corporate update.

“We made solid progress on our key priorities in 2023,” says Neil F. McFarlane, president and chief executive officer of Zevra, in a release, who notes that one of the company’s key priorities for 2024 is to advance the KP1077 development program in sleep disorders.

He says in a release, “We are encouraged by the positive data from our phase 2 study of KP1077 in patients with idiopathic hypersomnia. KP1077 has been well tolerated while demonstrating early signs of differentiated clinical benefits. These data will help inform our registrational study, which we will discuss with FDA at an end of phase 2 meeting.”

Recent business and corporate highlights for KP1077:

  • KP1077 (serdexmethylphenidate, or SDX), an investigational therapeutic candidate both for the treatment of idiopathic hypersomnia, a rare sleep disorder characterized by excessive daytime sleepiness, and for the treatment of narcolepsy:
    • On March 26, 2024, the company reported positive topline data from its placebo-controlled, double-blind, proof-of-concept phase 2 study of KP1077 in patients with idiopathic hypersomnia. KP1077 was well-tolerated at all dose levels evaluated in the trial, including the highest dose of 320 mg daily, regardless of dosing regimen (once or twice daily), supporting the study’s primary endpoint of safety and tolerability.
    • KP1077 produced clinically meaningful improvement in excessive daytime sleepiness, as assessed by change from baseline in the Epworth Sleepiness Scale. This improvement was maintained during both the five-week open-label titration period and throughout the two-week double-blind withdrawal period for both dosing regimens. 
    • Patients administered KP1077 showed benefits in change from baseline for the Idiopathic Hypersomnia Severity Scale, Sleep Inertia Visual Analog Scale, and Brain Fog severity Scale at the end of the open-label dose titration, and at the end of the double-blind withdrawal period.
    • The study successfully fulfilled the objectives of providing key information for the design of a potentially pivotal efficacy trial, and the results of the secondary efficacy endpoints are supportive of initiating a phase 3 trial of KP1077. The company plans to request an end-of-phase 2 meeting with the US Food and Drug Administration to seek guidance on the phase 3 clinical trial design.
    • The company will present new data from a phase 1 study completed under the narcolepsy Investigational New Drug application and the final results from its phase 2 study of KP1077 in idiopathic hypersomnia at the upcoming SLEEP 2024 conference.  

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