Press release
KemPharm Announces Submission of Investigational New Drug Application for Phase 2 Trial of KP1077 in Idiopathic Hypersomnia (IH)
Upon IND clearance, KemPharm anticipates initiating KP1077 Phase 2 IH trial as early as the second half of 2022 CELEBRATION, Fla., May 05, 2022 (GLOBE
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"Upon IND clearance, KemPharm anticipates initiating KP1077 Phase 2 IH trial as early as the second half of 2022 CELEBRATION, Fla., May 05, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, today announced the submission of an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder. KemPharm successfully completed the pre-IND meeting process with the FDA in February 2022. During these interactions, KemPharm 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 (SDX). SDX is the sole active pharmaceutical ingredient (API) in KP1077. “We are excited to begin the clinical development process for KP1077 as a potential treatment for IH, a rare sleep disorder characterized by multiple, debilitating symptoms for which few treatment options exist,” stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Our optimism surrounding KP1077 is based on the preclinical and clinical data regarding SDX, which includes the recent results from a Phase 1 clinical trial exploring the safety and pharmacokinetics (PK) of SDX administered in doses higher than currently approved. The data suggest that SDX produces a smoother, more gradual release of d-MPH that may avoid the adverse events associated with large and rapid exposure fluctuations that may be experienced with other stimulant-based therapies. We believe KP1077 could provide an improved treatment option for patients with IH and other sleep disorders by addressing the most debilitating symptoms of IH, including excessive daytime sleepiness (EDS), extreme difficulty waking up (sleep inertia), severe “brain fog”, and falling asleep unintentionally and/or at inappropriate times, even after adequate or prolonged nighttime sleep.” Once the clinical investigation proposed in the IND has been cleared to proceed by the FDA, KemPharm plans to initiate its Phase 2 clinical trial ...