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Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia
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KP1077 demonstrates clinically meaningful benefits for key IH symptoms
Top-line data provide key information for the design of a Phase 3 study
CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data 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). This proof-of-concept study was not powered to demonstrate statistical significance. The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.
“Zevra’s Phase 2 trial evaluating KP1077 as a treatment for IH demonstrated clinically meaningful impact and encouraging outcomes on both clinical safety and efficacy,” stated Christopher Drake, PhD, FAASM, DBSM, Principal Investigator of the study. “During the open-label dose titration period, patients showed robust improvements in IH symptom severity, including excessive daytime sleepiness that were maintained during the double-blind withdrawal period. At the end of the study, patients randomized into the KP1077 treatment group also demonstrated improvements in patient reported IH specific outcomes. We look forward to presenting the final results of the Phase 2 trial at the upcoming SLEEP 2024 annual meeting.”
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“We’re thankful to the patients in the Phase 2 clinical trial for their participation in advancing the investigational treatment, KP1077, for IH,” said Neil McFarlane, Chief Executive Officer of Zevra. “We believe KP1077 has strong potential to alleviate the immense burden of key IH symptoms, including excessive daytime sleepiness, sleep inertia and brain fog, and could provide a differentiated treatment option for patients underserved by currently available therapies. We would also like to thank our IH-focused patient advocacy group partners and supporters for making this clinical trial possible. Their partnership in raising awareness for this study and supporting trial enrollment has been crucial for its success.”
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