Revelation Biosciences Inc (NASDAQ: REVB), a clinical-stage life sciences company, on Monday announced positive safety and biomarker data from its Phase 1 clinical study of Gemini (RVL-HV02), Revelation's proprietary TLR4 agonist. The study met its primary endpoint, confirming the safety and tolerability of escalating doses of Gemini and identified a maximum tolerated dose in healthy volunteers. Statistically significant dose-dependent upregulation of key biomarkers was observed, demonstrating Gemini's immunostimulatory preconditioning effect.

Conducted in Australia with 40 healthy participants aged 18 to 55, the study evaluated escalating doses of intravenously administered Gemini. Results showed significant dose-dependent changes in circulatory biomarkers, reflecting the expected pharmacology of TLR4 stimulation. Significant increases in interleukin-1RA, neutrophil gelatinase lipocalin, c-reactive protein and IL-6 were observed without significant increases in TNF-α and IL-1β, indicating Gemini's potential to reprogram the innate immune response.

Gemini was well-tolerated, with adverse events including transient headache, chills, body aches and vomiting, consistent with preclinical findings. The study's results and the established maximum tolerated dose will guide dose level selection in a planned Phase 1b study in chronic kidney disease patients.

The TLR4 agonist is being developed as a preconditioning therapy for acute kidney injury due to cardiac surgery and to reduce post-surgical infection severity. Revelation's preclinical studies suggest Gemini can reduce the severity and duration of acute kidney injury and bacterial infections and prevent kidney tissue scarring in chronic kidney disease models.

Revelation Biosciences focuses on harnessing trained immunity for disease prevention and treatment, with ongoing programs evaluating Gemini for various indications.