In its third-quarter business update, Zevra Therapeutics Inc designated KP1077, its investigational drug in development for idiopathic hypersomnia and narcolepsy, as a pivotal focus area.
According to Neil F. McFarlane, president and CEO of Zevra, in a release, the company aims to complete the phase 2 trial of KP1077 in idiopathic hypersomnia and prepare to advance into phase 3.
Last month, Zeva reported interim data from the open-label dose titration phase of its phase 2 clinical trial evaluating KP1077 in patients with idiopathic hypersomnia. Results demonstrated KP1077 was well-tolerated at all dose levels and both dosing regimens.
The interim data related to the secondary and exploratory endpoints showed marked improvements in patient-reported assessments of key idiopathic hypersomnia symptoms from the open-label titration phase, including excessive daytime sleepiness, sleep inertia, and brain fog.
Top-line data from the completed trial are expected in the first half of 2024 after all patients have completed the double-blind withdrawal phase. The combined open-label interim and upcoming topline data are expected to also provide information related to secondary and exploratory endpoints, including excessive daytime sleepiness, sleep inertia, and brain fog. The results from the completed phase 2 trial will inform the final design of the anticipated phase 3 trial in idiopathic hypersomnia expected to be initiated by the end of 2024.
A phase 1 clinical trial under the narcolepsy Investigational New Drug was completed for KP1077 in healthy volunteers. Data generated from this trial will be analyzed alongside the phase 2 idiopathic hypersomnia data to support clinical development of both narcolepsy and idiopathic hypersomnia programs.
During the quarter, Zevra also named Neil F. McFarlane president and CEO of Zevra.