Revelation Biosciences' Gemini Data at AKI & CRRT

Revelation Biosciences’ PRIME study showed that Gemini was associated with reductions toward reference ranges in select hyperinflammatory biomarkers in patients with stage 3-4 CKD and produced exploratory signals consistent with improved immune function that may be mechanistically relevant to acute kidney injury (AKI).

PRIME focused on hyperinflammatory biomarkers and measures related to immune function and reported biomarker changes consistent with immune rebalancing—an effect that may reflect restoration of more regulated innate immune responses rather than indiscriminate immunosuppression.

Improved regulation of immune responses could, in theory, reduce susceptibility to secondary infections and support organ recovery after injury, although such clinical outcomes were not assessed in PRIME. The study’s immunologic signals and favorable biomarker directions with Gemini provide a biological rationale to prospectively evaluate both clinical and immunologic endpoints in AKI-focused efficacy trials.

Initiation of GMP manufacturing establishes a clinical-grade, process-validated supply suitable for IND-enabling activities. This milestone addresses a key operational prerequisite for larger randomized, multicenter studies and advances Gemini’s readiness for subsequent stages of clinical development.