Thursday, April 25, 2013

Daiichi Sankyo Exudes confidence in Edoxaban, enters into agreement with Perosphere to conduct Clinical Trial to Evaluate the Efficacy and Safety of PER977 to Reverse the Anticoagulant Activity of the Investigational, Oral, Once-Daily Factor Xa Inhibitor Edoxaban

Daiichi is yet to announce the Phase 3 data on edoxaban in Stroke prevention in Atrial Fibrillation, but it seems they are pretty confident of a positive outcome. Daiichi today announced that they have entered into an agreement with Perosphere Inc. to conduct clinical trial to evaluate the safety, tolerability and effectiveness of PER977 to reverse the anticoagulant activity of edoxaban, Daiichi Sankyo’s investigational oral, once-daily, direct factor Xa-inhibitor. 
Edoxaban is currently being evaluated in two Phase 3 trial - Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor Xa Next GEneration in Atrial Fibrillation), which are evaluating edoxaban, administered once-daily, for treatment and prevention of recurrence of VTE in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and for the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation, respectively.

PER977 is a synthetic, small new molecular entity being developed by Perosphere that has been shown in pre-clinical studies to directly bind to heparins as well as circulating direct factor Xa- and IIa-inhibitors and therefore has the potential to reverse their anticoagulant effect. PER977 does not bind to blood coagulation factors or other blood proteins. In pre-clinical studies, PER977 has demonstrated the ability to reverse the anticoagulant effects of direct factor Xa- and IIa-inhibitors in vitro and ex vivo in animal and human models. PER977 reverses anticoagulant activity within 30 minutes after intravenous administration and has a clearance half-life of approximately hours.

Need for an antidote 
“Novel oral anticoagulants like Edoxaban are being developed to help address the limitations of older anticoagulant agents, such as the need for frequent dose adjustments and monitoring,” said Jack Ansell, M.D., Professor of Medicine, NYU School of Medicine, and an advisor to Perosphere. “However, during severe bleeding or the need for emergency intervention, there is no established therapy to reverse the anticoagulant activity of these agents.”

Edoxaban is an investigational, oral, once-daily anticoagulant that specifically and reversibly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting.1,8 Edoxaban is currently approved only in Japan, since April 2011, for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery, under the brand name Lixiana.

About Perosphere
Perosphere is a specialty pharmaceutical company with internationally recognized drug delivery expertise. The company identifies market opportunities where application of drug delivery technology to a drug already on the market can create a new medical use for that drug or enhance its safety, efficacy or ease of use. Perosphere also selectively identifies and develops new chemical entities and other therapeutics that can be used as “rescue” drugs. PER977, a clinical-stage anticoagulant reversal agent for direct factor Xa- and IIa-inhibitors, is Perosphere's lead drug candidate. For more information, please visit

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