Daiichi Sankyo, Perosphere To Conduct Phase 3 Studies On Anticoagulant Reversal Agent

Daiichi Sankyo plans to support and co-sponsor Phase 3 clinical studies of Perosphere’s PER977, an anticoagulant reversal agent. The third clinical trial collaboration agreement between the two companies was announced in a press release. The oral, once-daily, direct factor Xa-inhibitor is a synthetic, new molecular entity (NME) that binds to heparins and direct factor Xa- and IIa-inhibitors, thereby reversing their anticoagulant effect.

Perosphere is seeking Food and Drug Administration (FDA) Accelerated Approval, intends to file a New Drug Application (NDA), and is seeking commercialization partners for PER977. Dr. Solomon S. Steiner, CEO of Perosphere, said, “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.”

Daiichi Sankyo and Perosphere Agreement

Under the terms of the agreement, Perosphere retains all worldwide rights to PER977. It will seek regulatory approval in the U.S. and the EU and proceed with commercialization upon approval. Daiichi Sankyo will make an upfront payment to Perosphere and confer additional payments based on milestones.

PER977

Perosphere seeks to use PER977 to reverse oral anticoagulants in emergent cases when immediate reversal is necessary. The agent acts against the new oral anticoagulants, low molecular weight heparins, and fondaparinux. The company also sees PER977 used in overdoses, surgeries, and traumas. To aid in diagnosis and treatment, Perosphere has also developed a measurement of the degree of anticoagulation in patients, which it believes may be better than standard laboratory tests for coagulation.

PER977 is a small, water-soluble agent that combines with heparin and other anticoagulant drugs, such as oral Xa and IIa inhibitors. The combination enables a reversal and a rapid re-establishment of normal blood coagulation. PER977 accomplishes the reversal effect by binding to the anticoagulant molecule. In several studies, the agent has completely reversed edoxaban, dabigatran, apixaban, rivaroxaban, low molecular weight heparin, unfractionated heparin, and fondaparinux. Reversal is rapid — within 30 minutes of IV administration — according to pre-clinical and Phase 1 and 2 studies. If Phase 3 clinical studies of PER977 show safety and efficacy, Perosphere would corner the market, as there are currently no approved drugs for anticoagulant reversal.