In a previously conducted Phase 1B, PMX-60056 demonstrated safety and efficacy in reversing heparin in healthy subjects. PMX-60056, one of PolyMedix’s lead compounds, is designed as a small synthetic molecule to reverse heparin-induced anticoagulation.
PolyMedix said that, the Phase 1B double-blind crossover study will be conducted at a single site in the US. Up to six healthy subjects will be randomised into two cohorts. All subjects will receive tinzaparin, an FDA approved LMWH, followed by two ten-minute infusions of either PMX-60056 or placebo.
In the trial, with the crossover design, on the second treatment day, each subject is expected to receive the alternate treatment, therefore, those that received PMX-60056 will receive placebo and vice versa. Thus, each subject will serve as their own control.
Reportedly, the objective of the study is primarily to assess the safety of using PMX-60056 in subjects that have received LMWH, and will also measure the ability of PMX-60056 to neutralize LMWH and normalize blood clotting time. The results from this Phase 1B study are expected at the end of the 2nd quarter 2010.
Earlier, in October 2009, PolyMedix has completed a similarly designed study in healthy subjects that had received heparin and PMX-60056. The results demonstrated that a single dose of PMX-60056 was well tolerated, and completely and rapidly reversed heparin and normalized blood clotting time in this study.
Nicholas Landekic, president and CEO of PolyMedix, said: “We believe bleeding complications associated with LMWHs represent a major unmet medical need for a LMWH reversing agent. There is no approved reversing agent for LMWH. We believe that PMX-60056 is unique in being the first and only LMWH reversing agent in development.
“This study will help us determine if PMX-60056 has the potential to offer important benefits and improvements in treating these patients at risk of bleeding complications, and may be the first drug developed for this important use.”