PolyMedix PMX-60056 meets Phase 1B/2 study endpoints

PolyMedix's Phase 1B/2 dose-ranging clinical study evaluating PMX-60056, a synthetic small-molecule designed to reverse heparin and low molecular weight heparin (LMWH) anticoagulants, has met the study endpoints regarding both the reversal of varying heparin levels and allowing re-anticoagulation and re-reversal.

PolyMedix will use the data from this Phase 1B/2 study to support the development of a Phase 2 clinical trial in surgical patients.

PMX-60056 Phase 1B/2 study was an open label, dose titration study designed to evaluate PMX-60056 in the reversal of surgical levels of heparin, and also in allowing for the possibility of re-anticoagulation.

PMX-60056 Phase 1B/2 study results showed that the drug reversed up to 350U/kg of heparin and didnot interfere with a second anticoagulation.

In the trial subjects that were re-anticoagulated with 100U/kg of heparin followed by a second dose of PMX-60056, showed a consistent response time to the initial heparin reversal.

Efficacy in the PMX-60056 Phase 1B/2 study was measured by ACT (Activated Clotting Time), a standard bedside measurement, which increased to as high as 574 seconds upon the administration of heparin.

In this study, ACT readings for all subjects were at or near normal (100 seconds) in less than three minutes after the end of dosing of PMX-60056.

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Source: Pharmaceutical Business Review