PolyMedix Inc. has stopped enrollment in two clinical trials for PMX-60056, its anticoagulant reversing agent, due to observations of reductions in blood pressure.
In these clinical studies, PMX-60056 showed activity in neutralizing both UFH and enoxaparin, as measured by activated clotting time (ACT) and anti-factor Xa activity, respectively.
In a statement, the company said it believes these side effects could be addressed with PMX-60056 being delivered in a larger volume over a longer infusion time. Given its limited resources and current capital market conditions, the company has made the strategic decision to not incur additional expenses relating to the PMX-60056 program and instead focus its development efforts and resources on PMX-30063.
The studies were a Phase 2 clinical trial for reversing the anticoagulant activity of unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention procedures, and a Phase 1B/2 clinical trial for reversing the anticoagulant activity of the low molecular weight heparin enoxaparin in healthy volunteers.
Nicholas Landekic, president and chief executive officer of PolyMedix, commented, “I am disappointed that we will not continue to fund the development of PMX-60056. We believe in the medical needs and commercial opportunities for an anticoagulant reversing agent such as PMX-60056, and plan to seek strategic partnerships to further develop the program. Given the recent positive results from our Phase 2 clinical trial with our defensin-mimetic antibiotic PMX-30063, and what we consider to be significant unmet medical needs and attractive commercial potential for the program, we are prioritizing our efforts based on available capital. We believe it is in the best interests of PolyMedix and our shareholders to dedicate resources and focus our future development efforts on our promising defensin-mimetic franchise.”
PolyMedix will continue to focus its development efforts on PMX-30063 and its infectious disease franchise in more advanced clinical trials and for additional potential uses, such as oral mucositis. PolyMedix recently announced positive results from its first Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI). A Phase 2B dose optimization study in ABSSSI is planned to commence later this year.
Release date: May 10, 2012
Source: PolyMedix Inc.
Filed Under: Drug Discovery