KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for KP879 (KP879 IND), concluding that the Company may proceed with its planned clinical investigation of the product candidate. KemPharm expects to initiate the clinical program for KP879 in 2021. In addition, the Company reported that it has completed its multi-phase process to regain its Nasdaq listing and restructure its balance sheet.
KP879 is being developed as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD), a condition for which there are no FDA-approved medications. KP879 utilizes serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate. SDX is also the primary active pharmaceutical ingredient (API) of KP415 and KP484, the Company’s product candidates which are intended for the treatment of attention-deficit/hyperactivity disorder (ADHD).
It is anticipated that certain data from previously completed research may be leveraged for KP879, which KemPharm believes could potentially streamline the development timeline of KP879.
“We are pleased that the FDA has accepted the KP879 IND, enabling us to initiate the clinical program for KP879 currently planned to begin mid-year 2021,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “KP879 showcases the potential of SDX as a platform technology. In addition to KP879, SDX is the primary API for KP415, our lead product candidate for the treatment of ADHD, which is currently under review with the FDA with an expected PDUFA date of March 2, 2021.”
Per the definitive collaboration and license agreement with an affiliate of Gurnet Point Capital (GPC) dated September 3, 2019, GPC holds an option to negotiate the terms of a new license agreement with KemPharm for the rights to develop and commercialize KP879 once the Company has established clinical proof-of-concept.