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PolyMedix halts studies of anticoagulant reversing agent

Monday, May 14 2012 | Comments
Evidence Grade 0 What's This?
PolyMedix Inc. is discontinuing two clinical trials of PMX-60056, a drug the company has been developing as an anticoagulant reversing agent. 

The investigational compound was being evaluated in a Phase II study for its capacity to reverse the anticoagulant activity of unfractionated heparin in patients undergoing percutaneous coronary intervention procedures and in a Phase Ib/II trial for its capacity to reverse the anticoagulant activity of the low molecular weight heparin enoxaparin sodium in healthy volunteers.

According to PolyMedix, PMX-60056 showed activity in neutralizing both unfractionated heparin and enoxaparin in the trials, as measured by activated clotting time and anti-factor Xa activity, respectively. However, because of observations of reductions in blood pressure, the firm elected to stop enrollment in the studies. The company said it believes these side effects could be addressed if administration of the drug were changed so that PMX-60056 would be delivered in a larger volume for a longer infusion time.

PolyMedix also said it decided not to incur additional expenses in connection with the PMX-60056 program, given the firm's limited resources and current capital market conditions. Instead, the company plans to focus its development efforts on PMX-30063 and its infectious disease franchise.

PMX-30063 is a defensin-mimetic antibiotic that is being studied for different uses, including acute bacterial skin and skin structure infections (ABSSSIs) and oral mucositis. PolyMedix recently reported positive findings from a Phase II trial of the compound in patients with ABSSSIs caused by Staphylococcus aureus, including methicillin-resistant strains, and a Phase IIb dose-optimization study in ABSSSIs is planned to begin later this year.

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