LOUISVILLE, Colo., July 18 /PRNewswire-FirstCall/ -- Replidyne, Inc. announced today the initiation of Phase I clinical testing of its topical anti-infective drug candidate REP8839, being developed for treatment of skin and wound infections and the prevention of S. aureus infections including methicillin resistant S. aureus, or MRSA, infections in hospital settings. REP8839 is being developed in combination with mupirocin, a widely used topical antibiotic.
"Advancing our second product into clinical development is a very important step for Replidyne," stated Kenneth J. Collins, President and CEO. "We believe that REP8839 has the potential to be a significant addition to the treatment options for S. aureus infections, including those caused by MRSA. Advancing REP8839 into the clinic also further supports the important role that our research and development activities will play in the future of Replidyne."
The study will examine various concentrations of REP8839 alone and in combination with mupirocin versus a placebo control in a total of 110 healthy adults. The clinical endpoint is an evaluation of the irritancy of repeat applications of REP8839 alone and a REP8839/mupirocin combination to intact and abraded skin with daily dosing duration of 2, 14 and 21 days.
This study is the initial Phase I clinical trial for REP8839. It is anticipated that up to three Phase I clinical trials focused on treating skin and wound infections will be conducted for REP8839 in combination with mupirocin. The additional Phase I trials will assess the pharmacokinetics, as well as sensitization to re-treatment with the compound. It is expected that these planned Phase I studies will be completed in the second half of 2006.
About REP8839
REP8839 is an inhibitor of methionyl tRNA synthetase, which is an enzyme that plays an essential role in protein synthesis. Inhibition of methionyl tRNA synthetase results in reduced protein synthesis and attenuation of bacterial growth. REP8839 is being developed for topical use for skin and wound infections and prevention of S. aureus infections, including MRSA infections, in hospital settings. REP8839 has exhibited promising activity against S. aureus, including all known drug-resistant strains, in pre-clinical studies. The Company's Investigational New Drug application, or IND, for the clinical development of REP8839 in combination with mupirocin for topical use, was submitted to the FDA in May 2006. Replidyne believes that the distinctive mechanisms of action of the two drugs may greatly reduce the likelihood that S. aureus will develop resistance to this combination. The Company retains the worldwide rights to REP8839.
About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne's lead product, Orapem(TM), is a novel oral, community antibiotic that is expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. A NDA for use of Orapem(TM) for multiple indications was submitted in December 2005. The Company has entered into a partnership agreement with Forest Laboratories for the development and commercialization of Orapem(TM) in the US. An IND for Replidyne's second drug candidate, REP8839, was submitted to the FDA in May 2006. REP8839 is a topical anti-infective product being developed for treatment of skin and wound infections, and the prevention of S. aureus infections, including MRSA infections, in hospital settings. Replidyne is also pursuing the development of other novel anti-infective products based on its in-house discovery research platform and library of proprietary compounds.
Safe Harbor
This press release contains forward-looking statements about Replidyne, Inc. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company's ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company's product candidates and the Company's ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company's ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company's sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company's Form S-1 filed with the SEC.
Replidyne, Inc.CONTACT: Mark L. Smith, Chief Financial Officer of Replidyne, Inc.,+1-303-996 5503
Web site: http://www.replidyne.com//
