NORTH LIBERTY, Iowa, June 11, 2012 (GLOBE NEWSWIRE) -- KemPharm, Inc. today presented key preclinical findings from KP511, the Company's first-in-class oral hydromorphone prodrug, at the 2012 International Conference on Opioids. KP511 exhibited superior pharmacological and physicochemical characteristics that may suggest an improved safety profile compared to currently marketed hydromorphone products, including potential reduction or elimination of opioid-induced constipation (OIC). KP511 may also limit abuse potential due to its inherent abuse-deterrent properties as a prodrug, as well as its tamper-resistant properties, which make it difficult to extract active hydromorphone from the prodrug until it is cleaved by natural enzymes in the body. The company expects to file an IND for KP511 in mid-2013 and anticipates conducting a Phase 1 clinical proof-of-concept trial shortly after.
Sven Guenther, PhD, Vice President of Research for KemPharm, commented, "As this conference highlights, opioids are an important class of molecules for the management of pain. It is vital for physicians to have safer options that alleviate some of the negative side effects of opioid analgesics, such as OIC, as well as the liabilities related to potential drug abuse, while still providing effective pain relief. KemPharm is committed to advancing its pipeline of opioid prodrugs, with the goal of creating improved products that address unmet needs in this large global market."
In a poster titled, "KP511. A Novel Opioid Pain Therapy with Reduced Abuse Potential and Improved Safety", KemPharm disclosed that the exposure to hydromorphone released from KP511 is bioequivalent to the parent drug following oral administration in rats. Importantly, OIC is likely to be reduced, or even prevented, by KP511. Receptor binding studies indicated that KP511 had no significant binding affinity at the opioid receptors found in the gastrointestinal tract that are responsible for causing OIC, including mu, delta, kappa, and orphanin type receptors. In addition, preclinical studies showed that exposure to hydromorphone plateaus at supratherapeutic doses, which may indicate the potential for oral overdose protection. Chemical tampering with KP511 via methods used commonly by opioid abusers resulted in products with reduced oral, intranasal, and intravenous bioavailability, which may further decrease the abuse potential of KP511.
KP511 is the second product candidate in KemPharm's pain therapy portfolio, which also includes KP201, a prodrug of hydrocodone that is on track for an NDA filing in mid-2013. Both of these drug candidates were identified using the Company's Ligand Activated Therapy (LAT) approach.
About KP511
KP511 is the second product candidate in KemPharm's pain therapy portfolio. It is a first-in-class oral prodrug of hydromorphone that has exhibited superior pharmacological characteristics in preclinical studies. These studies suggest a vastly improved safety profile compared to currently marketed hydromorphone products, as well as possibly reducing or preventing symptoms of OIC.
KP511 also features tamper resistant properties that make it difficult to extract hydromorphone from the prodrug, which is not active until cleaved in the body. KP511 is currently being evaluated in additional preclinical studies. The company expects to file an IND mid-2013 and anticipates conducting a Phase 1 clinical proof-of-concept study shortly after.
About KP201
KP201, KemPharm's lead clinical prodrug candidate for the treatment of moderate to severe pain, is a prodrug of hydrocodone. Preclinical studies suggest that KP201 may potentially 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 KemPharm
KemPharm is focused on the discovery and development of NCEs to treat serious medical conditions through its proprietary and broadly applicable LAT prodrug approach. KemPharm utilizes its LAT prodrug technology to generate improved versions of FDA approved drugs. KemPharm'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 primarily focused on developing candidates for pain and other central nervous system disorders. www.kempharm.com
Forward Looking Statements and Information
This release contains forward-looking statements which are not necessarily 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'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 such statement to reflect the occurrence of events or circumstances after the date hereof.