Press Release: Replidyne Phase II Pediatric Trial Meets Primary Objective
Replidyne Phase II Pediatric Trial Meets Primary Objective LOUISVILLE, Colo., March 6 -- Replidyne, Inc. announced today that it has completed its Phase II clinical trial using faropenem medoxomil (faropenem) in pediatric patients with acute otitis media (AOM), a common infection of the middle ear. Initial analyses of the study results show that it met its primary objective to show that faropenem was effective in eradicating pathogens from the middle ear and to permit the dose selection for Phase III trials in AOM. The study of over 300 pediatric patients examined four different doses of faropenem, administered twice daily as an oral suspension, and demonstrated a dose response in bacteriological eradication. All doses examined were well tolerated and there was no clear dose effect to tolerability. The trial included a double tap design where middle ear fluid is obtained both prior to and during treatment then submitted for culture. These cultures provide microbiologic documentation of faropenem's effectiveness in eradicating bacteria from the middle ear fluid. "We are pleased with the positive results and rich bacteriological and clinical data generated from this study, and look forward to presenting these data in more detail at an upcoming scientific conference," said Kenneth J. Collins, Replidyne's President and CEO. "The results give us confidence that we will be able to select an appropriate dose for Phase III studies. We plan to meet with the FDA in the second quarter to share these data and discuss Phase III trial design for faropenem in pediatric AOM." About Faropenem Faropenem is a member of the penem subclass within the beta-lactam class of antibiotics. Beta-lactams are generally characterized by their favorable safety and tolerability profiles, as well as their broad spectrum of activity, and as a result are often used as first line therapy in many respiratory and skin infections in adult and pediatric patients. About Acute Otitis Media Acute otitis media (AOM) is the most frequent pediatric bacterial infection that results in the prescription of an antibiotic and accounts for 30 million office visits in the US annually. Oral antibiotics are the most widely prescribed medicines to treat AOM in children and fall into two primary classes, macrolides and beta-lactams. According to IMS data, beta-lactams represent 88% of all pediatric antibiotic prescriptions for this illness. About Replidyne, Inc. Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne's lead product, faropenem medoxomil, is a novel oral, community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. Replidyne's second drug candidate, REP8839, is a topical anti-infective product under Phase I development for the treatment of skin and wound infections, including methicillin resistant S. aureus (MRSA) infections. Replidyne is also pursuing the development of other novel anti-infective products based on its in-house discovery research. Safe Harbor This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. 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 and most recent periodic report filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC's electronic data gather analysis and retrieval system (EDGAR) at www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.