Zevra Discusses SLEEP 2024 Updates – Wake Up Narcolepsy Community Update

June 4, 2024
Dear Tammy, Monica and the Wake Up Narcolepsy community,

Yesterday, during the SLEEP 2024 annual meeting in Houston, we announced positive final results from the Phase 2 clinical trial of KP1077. The placebo-controlled double-blind trial evaluated the safety and tolerability of KP1077 in patients with idiopathic hypersomnia. Results demonstrated that KP1077 was well tolerated and showed meaningful clinical improvements in patient-reported daytime sleepiness, sleep inertia, and brain fog.

Key takeaways from the Phase 2 clinical trial of KP1077 for idiopathic hypersomnia include:
• KP1077 was well-tolerated at all dose levels evaluated in the trial, including the highest dose of 320 mg daily, regardless of the dosing regimen: once (QD) or twice daily (BID).

  • Adverse events (AEs) were similar to other methylphenidate products
  • Most common AEs included insomnia, headache anxiety, decreased appetite and nausea
  • Most AEs occurred during the titration period, were mild, and did not lead to early discontinuation

• KP1077 produced clinically meaningful improvements in excessive daytime sleepiness (EDS) as assessed by change from baseline in the Epworth Sleepiness Scale (ESS) during both the 5-week open-label titration period which was maintained during the 2-week double-blind withdrawal period for both dosing regimens.

• At the end of the 7 weeks of treatment, patients administered KP1077 showed clinically meaningful benefits in change from baseline for the ESS, IH Severity Scale (IHSS), Sleep Inertia Visual Analog Scale (SIVAS) and Brain Fog Scale (BFS).

• The study successfully fulfilled the objectives of providing key information for the design of a pivotal efficacy trial, and the results of the secondary efficacy endpoints were supportive of initiating a Phase 3 trial of KP1077.

You can find additional information and detailed results from the Phase 2 clinical trial of KP1077 here.

Another highlight from the SLEEP 2024 annual meeting was the inaugural Idiopathic Hypersomnia Day (IH Day) on June 1, 2024. Because we share your commitment to raising awareness, educating the public and healthcare professionals, and sharing the experiences of those living with idiopathic hypersomnia, we were proud to participate in IH Day activities. IH day was held during the Hypersomnia Foundation’s Beyond Sleepy Conference and served as the kick-off to Idiopathic Hypersomnia Awareness Week, which runs through June 7, 2024. We are grateful for the opportunity this weeklong celebration allows us to engage in meaningful conversations with members of the IH community.

Learning from patient experiences and other experts in the field provides us with invaluable insights and a greater understanding of the IH disease state. We look forward to continued conversations and interactions through patient focus groups and other collaborations. We truly appreciate your support of our efforts to advance the treatment of idiopathic hypersomnia through clinical research as we believe KP1077 has potential to safely and effectively address the significant unmet medical need of those affected by IH.

We are committed to improving treatment options for people struggling with rare sleep disorders and, with your ongoing partnership, we are collectively creating positive change. If you have any questions, please feel free to reach out to us at patientadvocacy@zevra.com.

Kind regards,
The Zevra Team

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