The data from the study demonstrate that safe and well-tolerated single doses were achieved at suggested levels and that a beneficial therapeutic index may be possible. Further clinical development will continue for the initial indication for this drug as a treatment for pan-Staphylococcal infections.
This ascending single-dose intravenous pharmacokinetic and safety study met the necessary Phase I goals of defining both a limiting single dose and the plasma distribution or elimination kinetics.
A comparison between microbiologically effective drug levels (from preclinical studies in animals) and the plasma drug levels measured in this human study suggests that it should be possible to achieve clinically therapeutic levels with daily doses of PMX-30063 which are lower than those associated with any adverse effects seen in this single dose study.
PolyMedix plans to develop PMX-30063 initially for the indication of pan-Staphylococcal infections, the broad treatment of a wide range of Staph infections. Development will continue next with a multi-dose study to confirm safety throughout the expected duration of a clinical course of treatment.
Nicholas Landekic, CEO of PolyMedix, said: The completion of this first clinical study for PMX-30063 represents a major milestone for PolyMedix, and we believe, for all of medicine. This novel antibiotic compound represents a potential fundamental breakthrough in treating infectious diseases.
We are very proud to be the first company to be developing this completely new type of antibiotic, and seek to address a major clinical need and market opportunity. We look forward to continuing with further clinical development of PMX-30063.