Archemix and Nuvelo Close Phase 1 Trial for Thrombin Inhibitor, ARC183
With 'Proof of Concept' Achieved, Companies Actively Pursuing an Optimized Second Generation Molecule
Archemix Corp. and Nuvelo, Inc. announced that they have closed a Phase 1 clinical trial evaluating ARC183 as an anticoagulant for potential use in acute cardiovascular settings such as coronary artery bypass graft (CABG) surgery. Preliminary results from the trial show that administration of ARC183 resulted in a rapid onset of anticoagulation, demonstrated stable, dose-related anticoagulation activity and that the effects of the drug rapidly reversed after administration of the drug infusion ceased. However, the amount of drug needed to achieve the desired anticoagulation for use in CABG surgery resulted in a sub-optimal dosing profile. For that reason, the companies have decided not to pursue development of ARC183, and instead are actively pursuing an optimized second generation molecule.
The Phase 1 study was an open-label dose-escalation trial designed to evaluate the safety, tolerability, anticoagulation activity and titratability of ARC183 in two cohorts. Dosing has completed in the first cohort, which included 40 healthy volunteers. The second cohort, which was to include 16 patients with coronary artery disease, was closed prior to dosing in all patients due to the decision by both companies to pursue a second generation molecule that could offer superior potency and efficacy than what was being observed with ARC183.
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