Revelation Biosciences’ Gemini Demonstrates 60% Cytokine Reduction in CKD Patients
In the PRIME study of stage 3 and 4 CKD patients, Gemini reduced elevated IL-1b and IL-6 levels by over 60% through 168 hours (p<0.03) and restored immunoresponsiveness up to 7 days (p<0.02). Revelation Biosciences plans a pivotal Phase 2/3 AKI trial later this year.
1. PRIME Study Data Presented
Revelation Biosciences presented additional PRIME study data showing Gemini’s ability to rebalance immune responses in stage 3 and 4 CKD patients up to seven days after a single dose.
2. Cytokine Reduction Results
In the study, over 85% of patients had at least one elevated cytokine predose, with more than 60% exhibiting high IL-1b and IL-6 levels. A single Gemini dose reduced the number of elevated cytokines by over 60% at all measured timepoints (p<0.01 at 2 hours, p<0.02 at 24 hours, p<0.03 at 168 hours).
3. Restoration of Immunocompetence
More than 60% of patients were non-responsive to stimulation predose. Gemini significantly restored normal responsiveness to LPS stimulation (p<0.02 at 24 hours, p<0.03 at 168 hours) and showed a trend toward improved HMGB1 response (p=0.06), while placebo showed no significant change.
4. Next Clinical Steps
Building on these results, the company plans to initiate a pivotal Phase 2/3 trial in acute kidney injury later this year to further evaluate Gemini’s therapeutic potential in inflammation-driven renal diseases.