Revelation Biosciences, Inc. announced the commencement of its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study. This study will evaluate escalating doses of intravenously administered Gemini in patients diagnosed with Stage 3 and 4 Chronic Kidney Disease (CKD). The US-based, multi-site, placebo-controlled study is designed to enroll up to forty patients across five cohorts.
Dosing of patients in the PRIME study is scheduled to begin in mid-February. The company anticipates releasing top-line data from this study, including safety, tolerability, and biomarkers of target activity, by mid-year. This data will be crucial for supporting future development in both the GEM-CKD and GEM-AKI programs.
The initiation of this clinical study represents a significant advancement for Revelation Biosciences and its Gemini platform. It moves the company closer to potentially offering a novel therapeutic approach for chronic kidney disease, a condition with substantial unmet medical needs. This milestone reflects the culmination of the team's efforts in advancing Gemini.
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