Zevra Therapeutics Announces Positive Final Results from Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia at SLEEP 2024 Annual Meeting - Seite 3

The results from each study were discussed during two poster presentations in Hall A3, Poster Presentation Session P-13:

• Title: Safety and Efficacy of KP1077 in a Phase 2, Double-blind, Randomized Trial in Patients with Idiopathic Hypersomnia
  Date/Time: June 3, 2024, 10 a.m. to 11:45 a.m. CDT

• Title: Pharmacokinetics of Morning and Nighttime Doses of KP1077, an Investigational Treatment for Idiopathic Hypersomnia
  Date/Time: June 3, 2024, 10 a.m. to 11:45 a.m. CDT
  

Representatives from Zevra Therapeutics are also available during exhibit hours at Booth #1421 for additional discussion. Zevra proudly supports the Hypersomnia Foundation’s mission to raise awareness, educate, and uplift the voices of those living with idiopathic hypersomnia and was proud to participate in the inaugural Idiopathic Hypersomnia Day (IH Day) on June 1, 2024. IH Day, held in Houston during the Hypersomnia Foundation’s BeyondSleepy Conference, served as the kickoff to Idiopathic Hypersomnia Awareness Week, which runs through June 7, 2024.

About the KP1077 Phase 2 Trial
The Phase 2 clinical trial was a double-blind, placebo-controlled, randomized-withdrawal, dose-optimizing, multi-center study that evaluated the safety and efficacy of KP1077 for the treatment of IH. Part 1 of the trial consisted of a 5-week open-label dose titration phase during which patients were optimized to one of four doses of KP1077 (80, 160, 240, or 320 mg/day). Part 2 of the trial entailed a two-week randomized, double-blind, withdrawal phase, during which two-thirds of the trial participants continued to receive their optimized dose while the remaining one-third received placebo. Participants were assigned into two evenly divided cohorts. The first cohort received a single daily dose just before bedtime, and the second cohort received half the daily dose shortly after awakening and the second half prior to bedtime. Zevra enrolled 66 adult patients with IH in 24 centers in the U.S. into the open-label titration phase of the study and 50 of those patients continued into the double-blind phase.

The primary endpoint was the safety and tolerability of KP1077. The major secondary efficacy endpoint was the change in Epworth Sleepiness Scale (ESS) total score. Additional secondary endpoints included 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.