Revelation Biosciences, Inc. announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for Gemini. This regulatory acceptance is a significant milestone, enabling the company to initiate its US-based Phase 1b clinical study. The study will evaluate Gemini as a preconditioning treatment in patients with chronic kidney disease (CKD).
The multi-site, placebo-controlled Phase 1b clinical study is designed to enroll up to 40 subjects across up to 5 cohorts. The primary endpoint of the study will be the evaluation of the safety and tolerability of a single dose of Gemini in CKD patients. Secondary and exploratory endpoints will assess pharmacokinetics and Gemini's potential to modulate the innate immune response.
The initiation of this Phase 1b study is expected in early 2025, marking a crucial step in Gemini's clinical development. Positive data from this study would support a subsequent Phase 2 study of Gemini for reducing the incidence, duration, and severity of acute kidney injury (AKI) in patients undergoing coronary artery bypass graft and/or cardiac valve surgery.
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