KemPharm Files IND for KP879 for the Treatment of Stimulant Use Disorder

CELEBRATION, Fla., Dec. 22, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin human clinical trials of KP879. KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).

If the KP879 IND filing is accepted by the FDA, KemPharm intends to initiate efficacy studies of KP879 in 2021. It is anticipated that certain data from previously completed KP415 research may be leveraged for KP879, including pharmacokinetic studies, which KemPharm believes could potentially streamline the development timeline of KP879. KP879 utilizes serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH). 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).

“Filing the IND with the FDA for KP879 is an important step in the ongoing development of what could potentially be the first FDA-approved pharmacotherapy for SUD,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Additionally, we believe that KP879 represents an important development opportunity as it may demonstrate the potential for SDX, our prodrug of d-MPH, to address indications beyond ADHD, while also highlighting the ability of our LAT technology to identify new prodrug products that address unmet needs in both large and other underserved markets.”

A New Drug Application for KP415 is currently under review with the FDA with an anticipated PDUFA date of March 2, 2021. KemPharm believes that the ability to develop multiple prodrug products from the same API with unique treatment benefits and commercial profiles is an important attribute of its Ligand Activated Therapy (LAT) prodrug technology.

Per the definitive collaboration and license agreement with an affiliate of Gurnet Point Capital (GPC), GPC holds an option to in-license KP879, in addition to certain other KemPharm pipeline programs.

About Stimulant Use Disorder (SUD):

Stimulant Use Disorders include those marked by abuse/misuse of cocaine, methamphetamines, prescription stimulant products that contain methylphenidate or amphetamine, and numerous designer stimulants including, for example, 3,4-methylenedioxypyrovalerone (MDPV) and 4-methylmethcathinone (mephedrone) (“bath salts”). According to the Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, among Americans older than 12 years, there were approximately 1.9 million current users of cocaine, 667,000 users of methamphetamine, and 1.7 million current misusers of prescription stimulants. To date, there are no FDA-approved medications for the treatment of SUD.