Zevra reports positive Phase 2 trial results for KP1077 in idiopathic hypersomnia

ZEVRA THERAPEUTICS, INC.

KP1077 well-tolerated at up to 320 mg/day; AEs similar to methylphenidate, mostly mild (insomnia, headache, anxiety).
ESS decreased ~9 points after 5 weeks; at week 7: ESS -9.4 (QD), -8.8 (BID); IHSS -16.1 QD, -12.3 BID.
Sleep Inertia VAS decreased 25.9 (QD) and 17.2 (BID); Brain Fog Scale decreased 23.8 (QD) and 22.3 (BID).
PK data supports nighttime dosing; European Commission granted Orphan Drug Designation for KP1077 in IH.

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