PolyMedix has completed the first two segments of a phase 1B clinical safety study with its antibiotic drug candidate, PMX-30063. PMX-30063 is small-molecule mimetic of host defense proteins in clinical development, intended for systemic administration. It has a mechanism of action distinct from other antibiotic drugs and is believed to make bacterial resistance unlikely to develop.
The data from the study demonstrated that administration of multiple doses of PMX-30063 at varying levels are safe and well-tolerated. The doses and blood levels of drug achieved in the study suggest that a beneficial therapy may exist. Further clinical development is planned to continue for the initial indication for the drug as a broad treatment for Staphylococcus infections.
The company said that the phase 1B blinded, randomised, placebo-controlled ascending multiple-dose study was designed to find the limiting tolerable dosage for PMX-30063 when administered as five daily doses, and to define the resulting plasma distribution/elimination kinetics.
In the first two segments of the study, 56 healthy volunteers were divided into 8 cohorts and received up to 5 doses of either PMX-30063 or placebo. The doses ranged from 0.1mg/kg to 0.6mg/kg per day and were administered as a single one-hour infusion every 24 or 48 hours. Dosing continued until a threshold was reached where more than one volunteer in a cohort tolerated fewer than five doses.
Reportedly, the third and final segment of the phase 1B study is continuing with the administration of PMX-30063 or placebo in healthy volunteers with infusion every 12 hours over five days. Two or three dose levels are expected to be given in the segment of the study.
The company said that after completion of the study with the dosing segment, it is expected to determine the next steps for the development of PMX-30063, including plans for phase 2 efficacy studies in patients with Staph infections, in 2010.
Nicholas Landekic, CEO of PolyMedix, said: “We are pleased with this data as they continue to support the potential benefits of our novel antibiotic compound in treating infectious diseases. These Phase 1B study results suggest that it may be possible to repeatedly achieve therapeutically effective levels of PMX-30063 with multiple dose administrations. In addition, these results represent another major advancement for PolyMedix, and we believe, for all of medicine.
“PMX-30063 is the first small molecule defensin mimetic in clinical development for the treatment of systemic infections, and such compound whose mechanism of action is intended to directly address the major problem of bacterial drug resistance. We believe that these two characteristics may allow us to address a major clinical need and market opportunity.”