Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Regado Biosciences has reported positive primary results from the Phase 2b clinical trial of the company's lead product, the anticoagulation system REG1.
Subscribe to our email newsletter
REG1 is a two-component system consisting of pegnivacogin, a highly selective Factor IXa (FIXa) inhibitor and anivamersen, its complementary specific active control agent.
The study results showed that ACUITY major bleeding following immediate sheath removal exhibited a dose response with bleeding rates decreasing with increasing levels of reversal.
Rates of bleeding were lower in the 75% and 100% reversal arms than heparin.
In addition, the incidence of ischemic events was lower in REG1 treated patients compared with those treated with heparin.
Adverse events (AEs) other than bleeding and ischemic events were rare and evenly distributed among the arms of the study.
The Phase 2b RADAR clinical trial enrolled in subjects admitted for ACS-unstable angina and myocardial infarction without ST-segment elevation (UA/NSTEMI) intended for cardiac catheterisation within 24 hours.
The objectives of the study were to verify that 1mg/kg of pegnivacogin resulted in near complete FIXa inhibition, to determine the dose of anivamersen, which after immediate arterial sheath removal, results in a bleeding rate lower than heparin.
The objective also included assessing the efficacy of REG1 as an anticoagulant system in an invasively managed ACS population.
The primary endpoint of the study was ACUITY bleeding (major and minor) at 30 days, while the secondary endpoint was a composite of death, myocardial infarction (MI), urgent target vessel revascularisation (TVR) or recurrent ischemia at 30 days.