Tecarfarin vs. Warfarin
Based on pharmaceutical properties and recent clinical data, Espero Biopharma’s drug candidate, Tecarfarin, could possibly offer an alternative to warfarin in patients who are CYP2C9 deficient (30% of population) and in patients who are on drugs that inhibit CYP2C9 (30% of population).
Based on the post-hoc analysis of EMBRACE AC study, 10% of the intent to treat patient population who have both a genetic impairment in CYP2C9 clearance and are on drugs that inhibit CYP2C9 clearance, these patients are expected to benefit from Tecarfarin.
Tecarfarin vs. non-monitored therapy (NMT)
(i.e. direct thrombin inhibitors and Factor Xa inhibitors)
In patients who have renal insufficiency where the creatinine clearance (Cr Cl) is between 30 and 50 ml/min, Tecarfain offers a potential alternative to NMTs. In addition, in certain patient populations where NMTs are contraindicated, Tecarfarin could potentially be an option. These patient populations include those with severe chronic renal insufficiency (Cr Cl < 30ml/min), patients with prosthetic heart valves; post MI and cardiomyopathies and mural thrombi.
In the overall population, Tecarfarin could be a choice because if a patient skips a dose of the short half life NMTs, one is at risk for stroke, pulmonary emboli or DVT. These newer anticoagulants have half lives of 6 to 9 hours while Tecarfarin has an anticipated 77-hour half life.
In patients who are at risk for bleeding, Tecarfarin has the potential to mitigate bleeding risk. It is likely to that the drug candidate can be assessed by monitoring International Normalized Ratio (INR) and if a patient starts to bleed, INR can be used to check if he or she is supratherapeutic (INR>5).
If a patient is bleeding as a result of taking Tecarfarin (i.e. whether or not he or she is supratherapeutic), the effects of the drug candidate are being developed to be reversed quickly with administration of Vitamin K or fresh frozen plasma (FFP), and the patient’s coagulation status (INR) re-checked.
In patients in whom compliance is questionable, Tecarfarin might allow physicians to check the INR to ensure the patient is actually taking this potential drug on a regular basis. Current data indicates that Tecarfarin may not require frequent monitoring unlike warfarin.