Revelation Biosciences (REVB) announced dosing of the first patient in the PRIME, or PReconditioning IMmunostimulatory Evaluation, Phase 1b clinical study of intravenous single ascending doses of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease, or CKD. The US-based, multi-site, placebo-controlled study will enroll up to forty patients in up to five cohorts. Top-line data comprising safety, tolerability, and key biomarkers of activity including attenuation of the inflammatory response are expected by mid-year. Data from the PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programs.
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