Zevra reports positive Phase 2 top-line data for KP1077 in idiopathic hypersomnia

ZEVRA THERAPEUTICS, INC.

KP1077 showed clinically meaningful improvement in excessive daytime sleepiness on ESS, maintained through open-label and double-blind phases.
Improvements also observed in IHSS, Sleep Inertia VAS, and Brain Fog severity scale at end of both open-label and double-blind periods.
Drug was well-tolerated at all doses (up to 320 mg/day); most common AEs were insomnia, headache, anxiety, nausea, decreased appetite.
Company plans to request end-of-Phase 2 meeting with FDA for guidance on Phase 3 trial design.
Study enrolled 66 patients; 50 continued into double-blind phase; not powered for statistical significance.

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