Zevra reported continued advancement of a phase 2 clinical trial evaluating KP1077 as a treatment for idiopathic hypersomnia. Interim efficacy and safety data are expected as early as the third quarter, with the potential for topline phase 2 data as early as year-end.
Data gathered from the Phase 2 trial in idiopathic hypersomnia will support the advancement of KP1077 into a pivotal phase 3 trial in patients with idiopathic hypersomnia, as well as inform the decision of whether to initiate a future phase 3 trial in patients with narcolepsy.
The company also recently expanded the clinical program for KP1077 by opening an Investigational New Drug application for narcolepsy, extending its potential to address multiple rare sleep disorders.
“Zevra is moving at full speed as a company strategically focused on developing and commercializing novel therapeutics designed to address the unmet needs of people with rare diseases,” says Christal Mickle, co-founder and chief development officer, in a release.
The investigational drug updates were announced as part of the company’s first-quarter corporate updates, in which Zevra also announced plans to begin a search for a new CEO to succeed Richard W. Pascoe, who will retire from his role as CEO on June 1.
Zevra appointed Mickle to serve as interim CEO and president, effective June 1.