PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a phase 2 clinical trial in Canada with its novel defensin-mimetic antibiotic, PMX-30063. PMX-30063 represents a new class of antibiotics, and is the first and only systemic antibiotic specifically designed to mimic the activity of human host defense proteins, the body's natural defense against bacterial infections.
"We appreciate Health Canada granting us approval to initiate this phase 2 clinical trial and look forward to continuing to work with Health Canada and other regulatory bodies for the clinical development of PMX-30063," commented Bozena Korczak, Ph.D., senior vice president, drug development & chief development officer at PolyMedix. "We have incorporated recommendations from Health Canada as well as the recently released FDA draft guidance for development of drugs for the treatment of acute bacterial skin and skin structure infections into the design of this phase 2 clinical trial."
The randomized, blinded, active controlled phase 2 clinical trial will be conducted at multiple sites in Canada. The study objective is to evaluate the safety and efficacy of PMX-30063 as an initial treatment for acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus. The trial will enrol up to 200 patients that have ABSSSI presumed to be due to either methicillin susceptible (MSSA) or methicillin resistant (MRSA) S. aureus. Patients will be randomized to receive one of three dosing regimens of PMX-30063 or daptomycin active control, and will have an early treatment assessment at 48 and 72 hours for clinical and microbiologic response. PMX-30063 will be administered once daily as intravenous infusions for five days followed by two days of once daily placebo. Daptomycin will be administered once daily for seven days. Following the treatment assessment, patients will be re-evaluated at day 10 to 15 for test of cure and again for safety at four weeks. An un-blinded interim analysis for safety and efficacy will be conducted after approximately 80 patients have completed treatment. Full study results are anticipated in mid-2011.
"Initiation of this phase 2 trial represents a significant achievement in the clinical development of PMX-30063," commented, Nicholas Landekic, PolyMedix's president and CEO. "In our completed phase 1 clinical trials, PMX-30063 was safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the trial. This phase 2 trial is intended to build upon these observations with this study in patients with ABSSSI. We are very proud to be developing the first and only systemic antibiotic drug with this mechanism of action, a defensin-mimetic with less likelihood of resistance than other antibiotics. We look forward to the continued development of PMX-30063 and being able to offer this critically needed new treatment for the major and growing problem of drug-resistant bacterial infections." PolyMedix has completed two phase 1 clinical trials in which a combined total of 77 healthy subjects received PMX-30063. In those clinical trials, PMX-30063 was safely administered in single or multiple doses without serious adverse effects. The only drug-related reactions of clinical importance to date have been paresthesias (abnormal sensations of numbness and tingling), which were mild, transient, non-disabling, and resolved on their own."
PolyMedix's novel antibiotic compound, PMX-30063, is a small-molecule that mimics the activity of human host-defense proteins (HDPs), the body's natural defense against bacterial infections. Unlike currently available antibiotics, HDPs kill bacteria by directly targeting bacterial membranes and disrupting them. Widespread resistance to this unique mechanism of action has not developed despite millions of years of evolution. With PMX-30063 designed to mimic HDPs, we believe that resistance is also unlikely to evolve to this novel antibiotic, making PMX-30063 a potential addition to the alternatives to combat the growing problem of bacterial resistance to currently available antibiotics. There are many forms of Staph bacteria which are resistant to many antibiotics, including marketed drugs. Studies by PolyMedix against 181 different drug-resistant forms of Staph bacteria have demonstrated the activity of PMX-30063 against all of them, including those strains resistant to marketed drugs. We believe the activity of PMX-30063 against a broad range of many types of Staph bacteria, including those non-responsive to currently marketed drugs such as vancomycin, daptomycin, and linezolid, distinguishes it among available and investigational antibiotic drugs.