Revelation Biosciences announces FDA acceptance of Gemini IND

Revelation Biosciences (REVB) announced that the United States Food and Drug Administration has accepted its investigational new drug application for Gemini. This game changing milestone allows the Company to initiate its US based Phase 1b clinical study to evaluate the potential of Gemini as a preconditioning treatment in patients with chronic kidney disease. The multi-site, placebo-controlled Phase 1b clinical study will enroll up to 40 subjects in up to 5 cohorts. The primary endpoint is evaluation of the safety and tolerability of a single dose of Gemini in patients with CKD. Secondary and exploratory endpoints will assess the pharmacokinetics, and the potential of Gemini to mobilize and attenuate the innate immune response to stress by measuring several predictive biomarkers of efficacy. Positive data from the Phase 1b study will enable a Phase 2 study of Gemini as a preconditioning treatment in patients with CKD to reduce the incidence, duration, and severity of acute kidney injury in patients undergoing coronary artery bypass graft and/or cardiac valve surgery.