NORTH LIBERTY, Iowa--(BUSINESS WIRE)--KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers with KP201, its novel abuse deterrent prodrug of hydrocodone for pain. KP201 is a new chemical entity (NCE) and is the most advanced opioid-based lead candidate in KemPharm’s emerging pipeline. KemPharm’s technology provides a way to impart improved properties to new drug candidates through chemical modification of existing FDA-approved drugs. KP201 now joins KemPharm’s clinical pipeline, which includes the more advanced Phase 2 candidate KP106, a prodrug for the treatment of attention-deficit hyperactivity disorder (ADHD).
“Preclinical studies suggest that KP201 may have reduced abuse potential and lower incidence of constipation when compared with currently approved narcotic treatments for pain,” commented Sven Guenther, Ph.D., Vice President of Research for KemPharm. “The exciting aspect of KP201 is that the abuse deterrent attributes are inherent to the molecule itself. As a result, KP201 is on a path to possibly become the first marketed opioid analgesic with innate abuse deterrent properties without requiring complex formulations.”
“The rapid development of KP201 using minimal resources while concurrently advancing our extensive pipeline is a testament to the creativity and hard work of the KemPharm team,” commented Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
About the KP201 Phase 1 Clinical Trial
The Phase 1 trial is a single dose, cross-over study in which twenty four healthy volunteers will receive KP201 5 mg, KP201 10 mg and Norco® 10/325 mg (hydrocodone bitartrate and acetaminophen), each separated by a seven day washout period. The objectives of the study include evaluation of the pharmacokinetics of KP201, hydrocodone and its active metabolite hydromorphone, as well as safety and tolerability.
About KP201
KP201, KemPharm’s lead prodrug candidate for the treatment of pain, is composed of hydrocodone attached to a ligand. Preclinical studies suggest that KP201 may exhibit unique abuse deterrent properties and lower incidence of constipation based on its physicochemical and pharmacological characteristics as compared with currently approved narcotic analgesics. KemPharm believes it may be able to use the 505(b)(2) regulatory pathway for a more rapid development timeline.
About KP106
KP106, KemPharm’s lead prodrug candidate for the treatment of ADHD, is composed of d-amphetamine and a ligand. In clinical studies, KP106 demonstrated pharmacokinetics indicative of an attenuated amphetamine exposure as compared to Vyvanse®. These data suggest that patients receiving KP106 may experience decreased side effects and decreased risk of abuse typically associated with stimulants. In addition, KemPharm is positioning KP106 to be the first ever proprietary thin film dosage form for ADHD. KemPharm projects the filing of a new drug application (NDA) for KP106 by the end of 2012.
About KemPharm, Inc.
KemPharm, Inc. is focused on the discovery and development of new chemical entities (NCEs) to treat serious medical conditions through its proprietary and broadly applicable Ligand Activated Therapy (LAT) prodrug approach. KemPharm utilizes its LAT prodrug technology to generate improved versions of FDA-approved drugs. Each NCE creates new composition-based intellectual property, may have a shorter development timeline and reduced development costs, and may be eligible for 505(b)(2) regulatory submission. The Company’s business strategy includes seeking strategic development partners following rapid clinical proof of concept demonstration in a Phase 1 trial. KemPharm also plans to explore discovery stage alliances with industry leaders, leveraging its prodrug know-how and LAT technology. KemPharm is developing candidates for ADHD, pain, other central nervous system disorders. www.kempharm.com
Forward Looking Statements and Information
This release contains forward-looking statements which are not based upon historical fact, including, without limitation, “will,” “should,” “expect,” “anticipate,” “plan,” “predict,” “believe,” “may” and “project.” Such statements, including statements relating to developments, progress, timelines, plans of our clinical and preclinical programs, and potential benefits of KemPharm Inc.’s product candidates, involve various assumptions, known and unknown risks, and uncertainties which may cause actual results or events to be materially different and adverse from those expressed in or implied by the forward-looking statements. Such assumptions, risks and uncertainties may relate to difficulties or delays in discovery, development, testing, and regulatory approval of the company’s product candidates, results that are inconsistent with preclinical results, unexpected adverse side effects, or inadequate therapeutic efficacy of the product candidates. The forward-looking statements in this release speak only as of this date, and KemPharm disclaims any obligation to update publicly any forward-looking statement to reflect the occurrence of events or circumstances after the date hereof.