Pharma Focus America

Zevra Therapeutics Announces FDA Acceptance of IND Application for KP1077 in Narcolepsy

Thursday, May 04, 2023

Zevra Therapeutics, Inc., a rare disease therapeutics company, today announced the acceptance of an Investigational New Drug (“IND”) application by the U.S. Food and Drug Administration (“FDA”) to begin a Phase 1 clinical trial of KP1077 in narcolepsy which is expected to provide additional information regarding the optimal dosing regimen. Zevra plans to initiate the first of several Phase 1 clinical trials of KP1077 in narcolepsy this year. These trials will support both the narcolepsy and idiopathic hypersomnia (“IH”) clinical development programs. Serdexmethylphenidate (“SDX”) is the sole active pharmaceutical ingredient in KP1077.

“The FDA’s acceptance of KP1077's IND for narcolepsy is an important step forward in the advancement of this novel therapy, creating a meaningful opportunity to expand our development efforts into this high-need indication,” said Christal M.M. Mickle, Chief Product Development Officer of Zevra. “We have conducted extensive research with SDX, and we believe that KP1077 has the potential to effectively treat both IH and narcolepsy types 1 and 2 with a differentiated safety profile.”

Zevra filed the IND for KP1077 for the treatment of narcolepsy in March 2023. Zevra also 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 (NCT05668754). Data from that study have the potential to support the advancement of KP1077 into a pivotal Phase 3 study in IH, as well as provide support in determining whether to initiate a Phase 3 trial in narcolepsy. During a related pre-IND meeting with the FDA, Zevra received confirmation that additional non-clinical studies were not needed to advance KP1077 for the treatment of idiopathic hypersomnia into clinical development due to the abundance of data already available on serdexmethylphenidate .



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