DARC has completed both Phase 1 and 2 clinical trials, where it has been found to be safe and well-tolerated.
To date, DARC has been used in 132 patients and has been found to be safe and well-tolerated. Our pharmacokinetic studies indicate that it is rapidly absorbed and distributed, with a short half-life of 20 minutes, which limits the peak exposure levels and the potential for acute and adverse reactions. Annexin is endogenous and ubiquitously expresses in humans.
DARC is administered currently via intravenous injection with development plans for nasal formulation in place.