Clinical-stage life sciences company Revelation Biosciences Inc (NASDAQ: REVB) announced on Wednesday that it has completed patient dosing in its Phase 1b PRIME (PReconditioning IMmunostimulatory Evaluation) study evaluating Gemini, its proprietary immunomodulatory therapy, in patients with Stage 3 and 4 Chronic Kidney Disease (CKD).
The US-based study enrolled five cohorts across three clinical sites. Data collection and sample analysis are ongoing, with results expected in Q3 2025. Key endpoints include safety data, hematologic changes, inflammatory response profiling in blood samples and biomarker analysis.
Gemini, an intravenously administered formulation of phosphorylated hexaacyl disaccharide (PHAD, is designed to attenuate inflammatory damage by reprogramming the innate immune system. The candidate is in development for multiple indications, including acute kidney injury (AKI), post-surgical infection and CKD progression.
Revelation plans to engage with the FDA later this year to discuss the future clinical development and regulatory strategy for Gemini.
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