Zevra Therapeutics Inc, a rare disease therapeutics company, provided second-quarter corporate updates, showcasing progress for KP1077, its drug candidate being investigated for the treatment of idiopathic hypersomnia and narcolepsy.
During the quarter, Zevra continued the advancement of a phase 2 clinical trial evaluating KP1077 as an investigational treatment for idiopathic hypersomnia. The trial is actively enrolling 48 adult patients with idiopathic hypersomnia at more than 30 sites in the United States.
Interim phase 2 data for the open-label titration phase of the trial are expected by the end of the third quarter, and topline phase 2 data in idiopathic hypersomnia is expected to be reported in the first half of 2024 based on the pace of enrollment.
Zevra’s forecast includes completion of the KP1077 development program for idiopathic hypersomnia up to New Drug Application submission.
The quarter also marked the expansion of the clinical program for KP1077 by opening an Investigational New Drug Application for narcolepsy, extending its potential to address multiple rare sleep disorders. A phase 1 clinical trial in healthy volunteers was initiated during Q2 and is currently enrolling.
By leveraging the data from the idiopathic hypersomnia program and the existing dataset generated as part of the Azstarys development program for serdexmethylphenidate, the sole active pharmaceutical ingredient in KP1077, Zevra can potentially initiate a pivotal phase 3 trial in narcolepsy sometime next year, according to a release from the company.