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news.PolyMedix has obtained clearance to start human clinical trials in the US with its anticoagulant reversing agent PMX-60056 under the investigational new drug application filed with the FDA.
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It is reported that PMX-60056 represents an entirely new class of drug, which PolyMedix calls a heptagonist, and is reportedly the only reversing agent for heparin and the low molecular weight heparins (LVMHs) in clinical development.
Nicholas Landekic, CEO of PolyMedix, said: “The clearance of the investigational new drug application (IND) for PMX-60056 represents a major milestone for PolyMedix. This novel heptagonist compound is the first of its kind, and represents a fundamental potential breakthrough for both cardiothoracic surgery and the treatment of bleeding problems with LVMHs.
“PMX-60056 is the only compound in clinical development intended to reverse the activity of LMWHs and heparin. We are proud to be the first and only company to be developing this completely new type of drug to address major clinical needs and market opportunities. We are also very proud of our productivity and efficiency, as this is our second regulatory clearance in the past three months.”