US-based pharmaceutical firm Perosphere has entered into a third clinical trial collaboration agreement to evaluate its investigational anticoagulant reversal agent PER977 in combination with Daiichi Sankyo's investigational oral, once-daily, direct factor Xa-inhibitor edoxaban in Phase III registration trials.
Being developed by Perosphere, PER977 is a synthetic, small new molecular entity that has been shown in preclinical, Phase I and Phase II clinical trials to directly bind to heparins as well as circulating direct factor Xa- and IIa-inhibitors reversing their anticoagulant effect.
The company said that PER977 does not bind to blood coagulation factors or other blood proteins and, in healthy volunteers, it reverses anticoagulant activity after a single intravenous administration of 100mg-300mg and does not require an extended infusion in order to maintain the reversal.
As part of the deal, Perosphere will seek regulatory approvals from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for PER977 to reverse the anticoagulant activity of edoxaban and commercialiSe the product in the US and EU.
Perosphere, which retains full worldwide commercial rights to PER977, will receive an upfront payment from Daiichi Sankyo and is also eligible to receive additional clinical development milestone payments.
Perosphere CEO Dr Solomon Steiner said: "Some potential anticoagulation reversal agents under evaluation are recombinant proteins or fully humanised monoclonal antibody fragments that are limited in the types of anticoagulants they can reverse.
"PER977 is a novel synthetic agent that is being investigated as a specific antidote for both direct factor Xa- and IIa-inhibitors as well as low molecular weight heparin, unfractionated heparin, and fondaparinux.
"We believe that a reversal agent that works against a broader range of anticoagulants would have a place in hospital formularies.
"We also expect that as a small molecule, PER977 would be an affordable anticoagulant reversal agent option."
Perosphere expects to pursue an Accelerated Approval pathway with the FDA and submit a new drug application (NDA) in June 2015 for PER977.
As part of the deal, Perosphere will initially seek regulatory approval in the US and EU for the reversal of the low molecular weight heparin, enoxaparin; unfractionated heparin, and if approved, edoxaban.