Regado Biosciences Inc., a biopharmaceutical company focused on the discovery and development of actively controllable aptamer therapeutics for the acute care setting, announced the publication in the Journal of Thrombosis and Thrombolysis of data from a single escalating-dose Phase 1 clinical trial of the REG2 anticoagulation system. The published data demonstrates the dose and concentration-dependent attenuation of thrombin generation and subsequent restoration of thrombin following reversal associated with REG2.

 

REG2 is a two-component system consisting of a subcutaneous depot formulation of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary intravenous injectable oligonucleotide active control agent, anivamersen. REG2 is being developed to be the preferred therapeutic option in high value sub-acute venous thrombosis indications such as DVT and VTE prophylaxis. REG2 will be an important part of the life cycle franchise strategy associated with Revolixys Kit which ultimately entails broad use throughout the hospital.

 

Christopher Rusconi, Regado’s chief scientific officer and co-discoverer of the Regado controllable aptamer technology, commented, “These results support the choice of FIXa as an excellent target for anticoagulant therapy. In addition, the concentration-dependent inhibition of thrombin generation observed in this study further supports the pegnivacogin dose selected for the REGULATE-PCI Phase 3 study of the companion product candidate, Revolixys Kit.”

 

The study included 32 healthy volunteers who were enrolled sequentially into four cohorts. Patients in cohorts 1-3 were randomized (3:1) to ascending doses of pegnivacogin, from 0.5 mg/kg to 3 mg/kg, and placebo, with no anivamersen administered. In cohort 4, all patients received 2 mg/kg open-label pegnivacogin and were randomized (1:1) to reversal by one dose or multiple doses over time of 1 mg/kg anivamersen. Parameters of the CAT assay included time to peak thrombin generation (PTm), endogenous thrombin potential, peak thrombin generation and velocity index (VIx).

 

Date: June 23, 2014

Source: Regado Biosciences