Summary: Zevra Therapeutics announced that Rene Braeckman, PhD, the company’s senior vice president of clinical development, will present top-line data from the phase 2 clinical trial of KP1077 (serdexmethylphenidate) in patients with idiopathic hypersomnia (IH) at Sleep Europe 2024. The study, which was a double-blind, placebo-controlled, randomized withdrawal trial, evaluated the safety, tolerability, and efficacy of KP1077. The trial enrolled 66 adult patients across 24 U.S. centers, with results showing positive outcomes for IH patients, including improvements in sleepiness, sleep inertia, and brain fog.
Key Takeaways:
- Positive Phase 2 Results for KP1077 in IH – The phase 2 clinical trial demonstrated that KP1077 was well-tolerated and improved key symptoms of idiopathic hypersomnia, including sleepiness and brain fog.
- Efficacy Measured by Multiple Endpoints – Secondary endpoints, such as the Epworth Sleepiness Scale, IH Severity Scale, and Sleep Inertia Visual Analog Scale, were used to measure the drug’s impact on patients, showing significant improvements.
- KP1077 Presentation at Sleep Europe 2024 – Zevra Therapeutics will present these findings at Sleep Europe 2024, highlighting the potential of KP1077 as a treatment for IH.
Zevra Therapeutics Inc announced that Rene Braeckman, PhD, Zevra’s senior vice president of clinical development, will present top-line data from the placebo-controlled, double-blind, randomized withdrawal phase 2 clinical trial evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH) at Sleep Europe 2024.
Presentation details are as follows:
- Oral Presentation
- Title: Safety and Efficacy of KP1077 in a Phase 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study in Patients with Idiopathic Hypersomnia
- Date/Time: Friday, September 27, 2024, 8:20 a.m. – 8:30 a.m. CET
- Location: Auditorium 1
- Poster Presentation
- Title: Safety and Efficacy of KP1077 in a Phase 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study in Patients with Idiopathic Hypersomnia
- Date/Time: Thursday, September 26, 2024, 12:00 noon – 1:30 p.m. CET, and 5:30 p.m. – 6:45 p.m. CET
- Category: Neurology
- Number: P771
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 five-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 US 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 total score. Additional secondary endpoints included the IH Severity Scale, the Sleep Inertia Visual Analog Scale, and a new scale to assess the symptoms and severity of brain fog.
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