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PolyMedix, Inc. (PYMX) has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056. The Phase 1B clinical study was a pilot proof-of-concept study conducted in the U.S. under an Investigational New Drug application (IND) filed with the U.S. FDA.
PMX-60056 completely reversed the anticoagulant effects of heparin and normalized blood clotting time in human subjects in less than 10 minutes. No serious adverse events occurred during the study of PMX-60056.
The primary endpoint of the clinical study was safety, specifically whether blood pressure decreases would be mitigated by the presence of heparin, and the secondary endpoint was efficacy, as measured by blood clotting time. The desired outcomes were no clinically significant decrease in blood pressure, and rapid reversal of activated clotting time (ACT), a standard bedside blood clotting measurement, and activated partial thromboplastin time (aPTT), a more accurate laboratory measurement of blood clotting time.
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