Revelation Biosciences, Inc. announced the completion of dosing for its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study. This study evaluates escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). A total of 5 cohorts were enrolled across 3 clinics in the United States, as planned.
With dosing now complete, the company is proceeding with sample analysis and data collection. Several study data sets are expected during the third quarter of 2025. These datasets will include safety parameters, changes in hematologic parameters, in vitro evaluation of the inflammatory response in peripheral blood mononuclear cells, and multiple biomarkers of activity.
CEO James Rolke thanked the investigators and participants for the rapid completion of dosing. The company looks forward to sharing the study data shortly and engaging with the FDA later this year to discuss future clinical development and approval pathways. This milestone is a crucial step towards advancing Gemini through the regulatory process.
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