Zevra Announces Phase 2 IH Clinical Trial Results – Wake Up Narcolepsy Community Update

Dear Deb and the Wake Up Narcolepsy community,

Today we announced positive top-line results from the Phase 2 clinical trial of KP1077 demonstrating clinically meaningful benefits for key idiopathic hypersomnia (IH) symptoms and providing critical information for the design of a Phase 3 study. You can read more about KP1077 and the top-line results announcement here.

We want to extend our gratitude to those who participated in this trial and our patient advocacy group partners and supporters for making this clinical trial possible. Your partnership in raising awareness for this study and supporting trial enrollment has been crucial for its success. We believe KP1077 has the potential to help address the unmet medical needs of those living with IH including excessive daytime sleepiness, sleep inertia and brain fog.

Those living with IH and other rare diseases are always at the center of our work, and we remain committed to our key priorities for individuals affected by rare sleep disorders such as idiopathic hypersomnia and narcolepsy.

We look forward to presenting the full extent of the completed results of the Phase 2 trial at the upcoming SLEEP 2024 annual meeting in June. In addition, a previously conducted Phase 1 clinical trial evaluating the impact of evening and morning dosing of KP1077, relevant for both IH and narcolepsy, was completed in volunteers and will be reported alongside the Phase 2 IH data.

We plan to request a meeting with the FDA to seek guidance on the Phase 3 clinical trial design and to engage in community focus groups to gain insights and considerations for the Phase 3 trial.

Thank you for your continued support and partnership. We are grateful for our work together and look forward to continuing to make positive strides for the patient communities we serve.

If you have any questions, please feel free to reach out to patientadvocacy@zevra.com

Warm regards,
The Zevra Team

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