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Perosphere, Daiichi Sankyo sign PER977 clinical trial agreement

Perosphere and Daiichi Sankyo have signed a clinical trial deal to evaluate the efficacy and safety of PER977 to reverse the anticoagulant activity of edoxaban.

According to the deal, Daiichi will support and co-sponsor a Phase 1 study assessing the effectiveness of PER977 in reversing the anticoagulant activity of its investigational oral, once-daily, direct factor Xa-inhibitor edoxaban.

Perosphere is developing the synthetic, small new molecular entity PER977 that has the potential to reverse their anticoagulant effect.

Several preclinical studies reveal that PER977 directly binds to heparins in addition to circulating direct factor Xa- and IIa-inhibitors and does not bind to blood coagulation factors or other blood proteins.

PER977 is shown to reverse anticoagulant activity in less than 30 minutes following intravenous administration and has a clearance half-life of around 1.5 hours.

Perosphere CEO Dr. Solomon Steiner said, "PER977 is a synthetic agent that has the potential to be an antidote for both direct factor Xa- and IIa-inhibitors as well as heparins. In pre-clinical studies, PER977 has been shown to remain stable for more than one year."

Daiichi Sankyo global drug development chief medical advisor and Drug Development for the Americas executive vice president Mahmoud Ghazzi said, "The initiation of this study, in collaboration with Perosphere, is an important next step in the development of edoxaban."