Armetheon releases results of Phase 1 tecarfarin trial

Armetheon Inc., a specialty pharmaceutical company that focuses on the development of novel small molecule drugs for the treatment of cardiovascular diseases, recently released the results of its Phase 1 clinical trial assessing how the pharmacokinetics (PK) of tecarfarin and of warfarin is affected by severe chronic kidney disease (CKD).

Tecarfarin is Armetheon’s lead candidate. The PK of the drug (renal clearance and plasma half-life) were not significantly altered by severe renal impairment. Warfarin, on the other hand, suffered a critical clearance reduction and a significant increase in half-life was experienced.

"We are greatly encouraged by the results of this Phase 1 study in CKD patients, which suggest that tecarfarin holds promise as an improved option for anticoagulation in these patients," Armetheon CMO and Head of Drug Development Dr. Detlef Albrecht said. "The safety and pharmacokinetics findings support the broadening of our enrollment plan for TACT to include patients with severe renal impairment, which represent a growing subgroup among anticoagulated patients and who are often excluded from pivotal Phase 3 cardiovascular studies of novel anticoagulant therapies."

Warfarin has been the choice treatment for decades when patients require anticoagulation, but physicians are now beginning to recognize its limitations.