Revelation Biosciences Advances Toward FDA Meeting on Acute Kidney Injury Treatment

Revelation Biosciences, Inc. has reached a significant milestone with the successful submission and acceptance of its end-of-phase 1 meeting package to the FDA. The meeting aims to discuss the regulatory pathway for Gemini, an experimental treatment for acute kidney injury (AKI). Revelation plans to initiate a later-stage clinical study in 2026 to further assess Gemini's efficacy in treating AKI.

Recently, the company reported positive data from its Phase 1b PRIME study in chronic kidney disease patients, where Gemini demonstrated safety and improved inflammatory response. The study highlighted the potential of Gemini to reduce inflammation significantly and restore normal cellular function. Revelation will publish these results and explore additional applications for Gemini in treating other inflammatory conditions.