Perosphere and Daiichi Sankyo collaborate on Ph III study of PER977 with edoxaban

USA-based Perosphere has entered into a third clinical trial collaboration agreement with Japanese pharma major Daiichi Sankyo (TYO: 4568) to study PER977, Perosphere's investigational anticoagulant reversal agent, in Phase III 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 I and Phase II 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 100mg to 300mg and does not require an extended infusion in order to maintain the reversal.

Under the terms of the agreement, Perosphere will seek US Food and Drug Administration and European Medicines Agency regulatory approval of PER977 to reverse the anticoagulant activity of edoxaban and commercialize PER977 in the USA and European Union. Perosphere retains full worldwide commercial rights to PER977. The US company will receive an upfront payment from Daiichi Sankyo and is eligible to receive additional clinical development milestone payments.