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     169  0 Kommentare Zevra Therapeutics Announces Positive Final Results from Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia at SLEEP 2024 Annual Meeting

    KP1077 was well tolerated and showed meaningful clinical improvements in patient-reported assessments of daytime sleepiness, sleep inertia, and brain fog

    Additional data presented on pharmacokinetics of morning and nighttime doses of KP1077

    European Commission has granted Orphan Drug Designation for KP1077 for the treatment of idiopathic hypersomnia

    CELEBRATION, Fla., June 03, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that final positive results from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate or SDX) in patients with idiopathic hypersomnia (IH) were presented in a poster at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held in Houston, TX, June 1-5, 2024. In addition, a second poster describing the pharmacokinetics of SDX when administered in the morning and at night was also presented.

    “We are encouraged by the positive results of the Phase 2 clinical trial, which serve as further support of KP1077 as a strong candidate to treat patients struggling with idiopathic hypersomnia,” said Adrian Quartel, MD, FFPM, Chief Medical Officer of Zevra. “We believe that KP1077 has great potential to provide a differentiated treatment option for patients underserved by currently available therapies.”

    This proof-of-concept study was designed to demonstrate safety and tolerability and was not powered to demonstrate statistical significance. However, the trial included several important secondary and exploratory endpoints, such as change in Epworth Sleepiness Scale (ESS) total score, the IH Severity Scale (IHSS), the Sleep Inertia Visual Analog Scale (SIVAS), and a new scale to assess the symptoms and severity of brain fog. These data gathered from the secondary endpoints will help inform the study design for a potential Phase 3 clinical trial of KP1077.

    “The results of the Phase 2 clinical trial support the safety and tolerability of KP1077 as measured by the primary endpoint of the study,” stated Christopher Drake, PhD, FAASM, DBSM, Principal Investigator of the study. “The clinically meaningful impact for both the safety and efficacy were well demonstrated by patients showing significant improvements in IH symptom severity such as sleep inertia, excessive daytime sleepiness (EDS), and patient-reported IH-specific outcomes.”

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    Zevra Therapeutics Announces Positive Final Results from Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia at SLEEP 2024 Annual Meeting KP1077 was well tolerated and showed meaningful clinical improvements in patient-reported assessments of daytime sleepiness, sleep inertia, and brain fog Additional data presented on pharmacokinetics of morning and nighttime doses of KP1077 …