Revelation Biosciences, Inc. announced the dosing of the first patient in its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study. This study is evaluating intravenous single ascending doses of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The US-based, multi-site, placebo-controlled study aims to enroll up to forty patients across five cohorts.
The company's CEO, James Rolke, expressed enthusiasm for the continued advancement of Gemini with this significant step. He highlighted the expectation for rapid enrollment and a positive outcome from the study, which aims to bring Gemini closer to helping patients in need. This milestone demonstrates tangible progress in the clinical development program.
Top-line data from the PRIME clinical study, including safety, tolerability, and key biomarkers of activity such as attenuation of the inflammatory response, are anticipated by mid-year. Data from this study will be instrumental in supporting future development for both the GEM-CKD and GEM-AKI programs, underscoring the importance of this initial dosing.
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