Zevra Therapeutics submits IND for KP1077 in narcolepsy

Zevra Therapeutics announced the submission of an Investigational New Drug application seeking authorization from the U.S. Food and Drug Administration to begin a Phase 1 clinical trial of KP1077 in narcolepsy. Once the clinical investigation plan proposed in the IND 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. Those data have the potential to support not only the advancement of KP1077 into a pivotal Phase 3 study in IH, but also a Phase 3 trial in narcolepsy. Zevra filed an IND application in May 2022 for the treatment of IH with KP1077 and subsequently initiated a Phase 2 IH study in December 2022. During a pre-IND 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.