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Replies to post #180166 on Biotech Values
10/06/14 12:14 PM
Perosphere Inc. announced today that it has entered into a third clinical trial collaboration agreement with Daiichi Sankyo, Inc. to study PER977, Perosphere's investigational anticoagulant reversal agent, in phase 3 registration studies with edoxaban, Daiichi Sankyo’s investigational oral, once-daily, direct factor Xa-inhibitor.
PER977 is a synthetic, small new molecular entity being developed by Perosphere that has been shown in preclinical and phase 1 and phase 2 clinical studies to directly bind to heparins as well as circulating direct factor Xa- and IIa-inhibitors reversing their anticoagulant effect. PER977 does not bind to blood coagulation factors or other blood proteins. In healthy volunteers, PER977 reverses anticoagulant activity after a single intravenous administration of 100 mg to 300 mg and does not require an extended infusion in order to maintain the reversal.
Perosphere intends to pursue an Accelerated Approval pathway with the FDA and file an NDA in June 2015 for PER977. Initially, Perosphere will seek regulatory approval in the U.S. and EU for the reversal of the low molecular weight heparin, enoxaparin; unfractionated heparin, and if approved, edoxaban. Subsequently, Perosphere will seek regulatory approval for reversal of the other factor Xa- and IIa-inhibitors: Johnson & Johnson's and Bayer HealthCare AG's Xarelto (rivaroxaban); Bristol-Myers Squibb Company's and Pfizer Inc.'s Eliquis (apixaban); and Boehringer Ingelheim GmbH's Pradaxa (dabigatran).
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