FDA Accepts Gemini IND from Revelation Biosciences

December 2, 2024

DENVER, Colo., Dec 02, 2024 (247marketnews.com)- Revelation Biosciences (NASDAQ: REVB) reported that the United States Food and Drug Administration (FDA) accepted its investigational new drug (IND) application for Gemini, which allows Revelation Biosciences 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 (CKD), scheduled to begin early 2025.

The Phase 1b clinical study will enroll up to 40 subjects in up to 5 cohorts in a  multi-site, placebo-controlled trial, with the primary endpoint being the evaluation of the safety and tolerability of a single dose of Gemini in patients with CKD. The study will also 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.

James Rolke, Revelation’s Chief Executive Officer, commented, “We are proud to receive acceptance of our IND for Gemini, marking our most important milestone to date for Revelation. By leveraging the unique properties of trained immunity, we are exploring new ways to improve patient outcomes. We will continue to move swiftly to initiate our Phase 1b clinical study in the near future.”

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