News
Replidyne Commences Clinical Trials For REP8839
Replidyne, Inc. (Nasdaq: RDYN) 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 EP8839/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.