Replidyne, Inc. today announced results from three Phase I trials studying REP8839, a novel topical antibiotic that has shown potent in vitro activity against major skin pathogens including methicillin-resistant S. aureus (MRSA).
The results of the Phase I trials show that topically applied REP8839 appears safe, well-tolerated and associated with low systemic exposure, or drug absorption into the bloodstream, which is desirable for a topical antibiotic treatment. Based on these results, Replidyne plans to initiate Phase II trials in children with impetigo, the most common bacterial skin infection, by the end of the year.
"REP8839 is a promising development candidate and has the potential to be an important treatment option for physicians in the ongoing fight against drug-resistant infections including MRSA, a growing public health concern," said Kenneth J. Collins, Replidyne's President and Chief Executive Officer. "With these safety data, we intend to move forward into Phase II trials to study the safety and efficacy of REP8839 in patients with impetigo and other skin and wound infections."
REP8839 was tested in three Phase I trials which collectively enrolled over 400 subjects. In the first Phase I trial, safety, tolerability and skin irritancy were tested following repeated daily application of REP8839, at three drug concentrations (1%, 2% and 4%), on intact and abraded skin. Irritancy scores comparable to placebo were recorded for all REP8839 exposed test subjects.
In the second study, in addition to safety, tolerability and dermal irritancy, systemic exposure was examined following repeated daily application of REP8839 on a larger surface area of intact and abraded skin. In all subjects, REP8839 was associated with low systemic exposure and low skin irritancy.
In the third study, a 2% formulation of REP8839 was tested for its ability to cause long-term sensitization and irritancy. No sensiti
zation reactions were recorded in any of the subjects, and low irritancy potential was confirmed. Additionally, in all Phase I studies no serious adverse events were observed in any study subject. Related medicine news :1
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