Zevra Therapeutics Inc, formerly KemPharm, announced the submission of an Investigational New Drug application, seeking authorization from the US Food and Drug Administration (FDA) to begin a phase 1 clinical trial of KP1077 in narcolepsy.
Once the clinical investigation plan proposed in the Investigational New Drug application has been cleared to proceed by the FDA, Zevra plans to initiate its first of several phase 1 clinical trials of KP1077 as early as the second quarter of 2023.
KP1077 is also currently being evaluated in a phase 2 clinical trial for the treatment of idiopathic hypersomnia (IH). Those data have the potential to support not only the advancement of KP1077 into a phase 3 study in IH but also a phase 3 trial in narcolepsy, according to a press release by Zevra.
“Our research of KP1077 in IH laid the groundwork for us to expand our clinical studies to examine its efficacy in narcolepsy, a chronic neurological sleep disorder,” says Richard W. Pascoe, CEO of Zevra, in a press release. “We are committed to advancing therapies for rare disorders, and our work to address narcolepsy and the treatment of excessive daytime sleepiness with KP1077 is an essential part of our commitment. Expanding existing trials in ways that support the advancement of therapies that the rare disease community needs is the core of Zevra’s mission.”
Zevra filed an Investigational New Drug application in May 2022 for the treatment of IH with KP1077 and subsequently initiated a phase 2 IH study in December 2022 (NCT05668754). During a pre-Investigational New Drug meeting with the FDA, Zevra received confirmation that additional non-clinical studies were not needed to advance KP1077 into clinical development due to the abundance of data already available on serdexmethylphenidate, the sole active pharmaceutical ingredient in KP1077.