PMX-60056

“PMX-60056 is designed to improve the safety and efficacy clinical outcomes of interventional cardiology procedures while also providing pharmacoeconomic advantages”

PMX-60056 is a synthetic, small-molecule designed to restore coagulation to help manage the balance of antithrombosis/anticoagulation and reduce the incidence of bleeding in certain interventional cardiology procedures, such as Percutaneous Coronary Intervention (PCI) and Coronary Arterial Bypass Graft (CABG), as well as, treat bleeding associated with low molecular weight heparins. PMX-60056 reverses the most common anticoagulants used in the hospital setting, heparin, and its derivative, low molecular weight heparin (LMWH). Because bleeding is a common side effect that can occur from use of these drugs, there is a significant unmet medical need for a pharmaceutical agent which can safely reverse their anticoagulation activity. PMX-60056 can immediately normalize blood clotting by reversing the anticoagulant action of these drugs within minutes, with the goal of allowing finer control of antithrombosis and anticoagulation.

PMX-60056 is currently being evaluated in a Phase 2 clinical trial to assess the safety and efficacy of reversing heparin in patients undergoing PCI procedures. PMX-60056 is also in a Phase 1B/2 dose response clinical trial to evaluate the safety and efficacy of reversing the LMWH enoxaparin in healthy volunteers. PolyMedix has completed three Phase 1B/2 trials --- a single dose trial to reverse heparin, a single dose trial to reverse LMWH, and a heparin dose-ranging trial. In all of these trials, PMX-60056 safely and rapidly reversed the anticoagulant activity of heparin and LMWH.

Unmet Medical Need

Patients undergoing certain interventional cardiovascular procedures are at risk of developing dangerous and sometimes life-threatening blood clots. To reduce this risk, patients often receive anticoagulant drugs that reduce or prevent the blood from clotting. 

It has been documented in the clinical literature that bleeding encountered in surgical procedures, which may be associated with the use of anticoagulants, can significantly increase hospital costs, patient recovery time and mortality. One potential way to reduce the incidence of bleeding or manage the severity of bleeding associated with anticoagulant use, may be to turn off the anticoagulant effect in a rapid, predictable, and controllable way, with the goal of restoring the blood’s ability to clot normally. PMX-60056 is designed to (i) provide physicians with greater flexibility and control in balancing clotting and bleeding risk, and (ii) treat emergency bleeding in patients on heparin and LMWH.

Market Opportunity

The potential uses for PMX-60056 are all medical situations that could be made safer or more effective by modulating the coagulation of the blood in patients receiving heparin or LMWH. This includes percutaneous coronary intervention (PCI, i.e. angioplasty, coronary stenting), heart surgery (e.g. coronary arterial bypass graft or CABG, pacemaker implantation, artificial heart valve surgery), orthopedic surgery, and bleeding events in anticoagulated patients.