Press release
KemPharm Completes KP1077 Pre-IND Meeting Process with FDA
KemPharm Positioned to Submit IND Application for KP1077 for Idiopathic Hypersomnia by Mid-2022 CELEBRATION, Fla., Feb. 23, 2022 (GLOBE NEWSWIRE) -- KemPharm,
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"KemPharm Positioned to Submit IND Application for KP1077 for Idiopathic Hypersomnia by Mid-2022 CELEBRATION, Fla., Feb. 23, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the successful completion of its pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration (FDA) for KP1077. KemPharm is developing KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder whose symptoms include excessive daytime sleepiness (EDS), extreme difficulty waking (sleep inertia), severe brain fog, and falling asleep unintentionally or at inappropriate times (narcolepsy). Per recent interactions with the FDA, KemPharm has confirmed that it may proceed with the submission of an IND application for KP1077, which the company expects to submit by mid-year 2022. As part of those interactions, the FDA provided collaborative feedback including that additional non-clinical studies will not be needed for the initiation of the KP1077 clinical development program given the data already available for serdexmethylphenidate (SDX). SDX is KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH) and the sole active pharmaceutical ingredient (API) for KP1077. “The successful completion of the pre-IND meeting process with the FDA for KP1077 affirms our plan to submit the IND application by mid-year 2022 and, following that, potentially initiate a Phase 2 trial of KP1077 in IH as early as the third quarter of 2022,” stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Noteworthy in our interactions with the FDA was confirmation that we will be able to utilize certain non-clinical studies from the KP415, now known as AZSTARYS®, and KP879 development programs as part of the data package for KP1077 due to both drugs being developed from SDX, our prodrug of d-MPH. This should allow us to realize meaningful cost and time savings, which may expedite the KP1077 program and, ultimately, the potential future filing of a New Drug Application (NDA).” Dr. Mickle continued, “The ability to rapidly develop novel, high-value treatments in areas of unmet need has been a cornerstone of the KemPharm approach. With KP1077, we are now advancing a novel product candid...