PolyMedix, a biotechnology company, has initiated dosing and commenced a Phase I clinical study in the US with its anticoagulant reversing agent PMX-60056 under an investigational new drug application filed with the FDA.
This first Phase I clinical trial will assess the safety of PMX-60056. The protocol for this study involves a dose-escalation study in healthy volunteers in which each subject will receive a single dose of PMX-60056. The subjects are grouped into different cohorts with different dosage levels which will allow for the study of the effects of increased dosages.
If the first clinical study is successfully completed, PolyMedix plans to initiate a second clinical trial as a proof of concept study to evaluate both safety and efficacy of PMX-60056. The second clinical trial, also to be conducted in healthy volunteers, will involve first administering heparin to subjects, and then afterwards administering a single dose of PMX-60056.
This study will assess both the safety of using PMX-60056 in heparinized subjects, and will also measure the ability of PMX-60056 to neutralize heparin and normalize blood clotting time. Following these clinical trials, significant additional clinical studies and regulatory submissions will be required to obtain regulatory approval from the FDA and other regulatory bodies before PMX-60056 could be commercially sold.
PMX-60056 represents an entirely new class of drug, which PolyMedix calls a heptagonist, and is said to be the only reversing agent for heparin and the low molecular weight heparins in clinical development.
Nicholas Landekic, CEO of PolyMedix, said: “The start of the clinical trial with PMX-60056 represents another major milestone for PolyMedix. This novel heptagonist compound is the first of its kind, and potentially represents a fundamental breakthrough both for cardiothoracic surgery and the treatment of bleeding problems with low molecular weight heparins.”
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