Therapeutic Focus

Our focus at Regado is on a conundrum that has existed since the introduction of the first antithrombotic therapy.  Simply put, the antithrombotic conundrum that physicians face comprises the desire and need to prevent harmful clots while allowing healing clots to form and develop normally.

Our initial efforts with the REG1 System (REG1)are in the area of arterial thrombosis and Percutaneous Coronary Intervention ( PCI)  which is a large and growing market.  In addition to PCI, there are myriad unmet medical needs and commercial opportunity for Regado Biosciences across all applications captured in the right hand column of the graphic.

Today, physicians use a variety of approaches to deal with the two consequences of suboptimal antithrombotic therapy- ischemia and bleeding.  In the case of dealing with unwanted ischemia, anticoagulants exemplified by heparin and bivalirudin (Angiomax®) are used.  These agents have demonstrated varying degrees of anticoagulant behavior and neither has an active control nor reversal agent.  In the case of bleeding, treatments include everything from frequent monitoring of anticoagulation levels to intense medical staff interaction, often using compression or closure devices and  in the case of major bleeding, transfusion.  Unfortunately, these approaches to address bleeding are not always effective and are expensive and disruptive to the healthcare system.

While the consequences of adverse ischemic events are very hazardous to the patient,  the gravity of the medical and pharmacoeconomic consequences associated with adverse bleeding events should not be underestimated.  The bar graph data on the left side of the slide shows that there is a direct correlation between increased bleeding and increased mortality rate (a correlation that seems to hold out, in some cases, to one year post event), while the data on the right side of the slide shows that there is significant increased monetary cost associated with bleeding.

At Regado Biosciences, we believe that we have found a solution to the antithrombotic conundrum using our exclusive paired aptamer- control agent technology.   Ours technology is designed to give physicians the ability to actively and directly control therapeutic effect,  either dialing up or down the anticoagulation, thus providing a safe and unique approach to personalized medicine without the existing costs to the patient and the healthcare system.

The table depicts  the list of characteristics of the optimal anticoagulant juxtaposed to the existing anticoagulant products in the market.  Regado Biosciences REG1 has all of the characteristics of an optimal anticoagulant and if it continues to demonstrate the clinical profile that we have seen to date, it will represent a new paradigm in anticoagulant therapy, becoming the established benchmark against which all other anticoagulants will be compared.

Not only will REG1 be developed clinically for PCI, but given its physio-chemical, pharmaceutical and medical properties and activity, REG1 will have applicability across all indications where anticoagulant therapy is currently used.  This is in stark contrast to existing therapies which are limited, for myriad reasons, in their use.  

It should be noted that  Regado Biosciences has a comprehensive antithrombotic pipeline which reflects the company’s expertise in discovery and development of therapeutic aptamers with active control agents.   Regado Biosciences is positioned to develop compounds for arterial and venous thrombosis as well as antiplatelet therapy with active control agents.  These are very large and growing markets in which significant opportunity exists for an innovative and novel products that can address key unmet medical needs. 

Taken together across all relevant markets and indications, the Regado Biosciences pipeline represents a worldwide commercial opportunity in excess of $20 billion.