PolyMedix, Inc, an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders, has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056. The phase-1B clinical study was a pilot proof-of-concept study conducted in the US under an Investigational New Drug application (IND) filed with the US Food and Drug Administration (FDA).

PMX-60056 completely reversed the anticoagulant effects of heparin and normalized blood clotting time in human subjects in less than 10 minutes. No serious adverse events occurred during the study of PMX-60056.

"We are very proud and happy to have completed this major step in the development of PMX-60056,” commented Nicholas Landekic, president & chief executive officer of PolyMedix. “PMX-60056 represents a new class of drug, which we call heptagonists, and we believe is the only compound being developed as a reversing agent for heparin and low molecular weight heparins (LMWHs). PMX-60056 may offer important benefits and improvements in treating the potential bleeding complications of heparin, which was targeted in this study, as well as LMWHs which we hope to investigate in future clinical studies. We hope that in the future PMX-60056 will allow physicians to continue to use heparin, the only anticoagulant currently available for open-heart surgery and kidney dialysis, with a new and unique reversing agent, and potentially the first reversing agent for LMWH’s.”

“I am encouraged by the promising results with PMX-60056. This drug could be an important addition to the medical armamentarium, and may address unmet clinical needs in reversing heparin as well as being potentially the first reversal agent for LMWH,” commented Dr Mark Stafford-Smith, of Duke University Medical Center, a clinical advisor to PolyMedix.

This phase-1B clinical study evaluated subjects who received heparin followed by PMX-60056 or placebo. Significant additional clinical studies and regulatory submissions, and regulatory approvals from the FDA and other regulatory bodies, will be required before PMX-60056 could be commercially sold as a reversing agent for heparin or for LMWHs. PolyMedix is currently evaluating plans for the continued clinical development of PMX-60056. There can be no assurances that future clinical studies will be successful, that required regulatory approvals will be obtained, or that the company will be able to market and sell any products based on PMX-60056.

Landekic said, “This study represents a validation of the capabilities and efficiency of PolyMedix’s structure-based drug design approach. In developing PMX-60056, we went from the very beginning of drug design to attaining a clinical efficacy endpoint while spending less than US$ 10 million in direct costs. We attribute this efficiency realized in developing PMX-60056 to our structure-based drug design approach, and the skill of our seasoned research and development leadership.”

Heparin and LMWH are widely used anticoagulant drugs to prevent blood clotting, the use of which has a risk of potentially serious bleeding side effects.

PMX-60056 was designed to bind to the pentasaccharide region found on heparin and LMWH.