Revelation Biosciences Inc. announced that it has commenced a first in human Phase 1 clinical study (RVL-HV02) to evaluate escalating doses of intravenously administered Gemini. The study is being conducted in Australia and is enrolling healthy individuals 18 to 55 years of age. Top-line data including safety, tolerability, and biomarkers of target activity are expected this summer.

Data from this Phase 1 clinical study will support future development across multiple indications. Gemini is the Company?s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with PHAD potentially preconditions the innate immune system to respond to a subsequent stress, such as ischemia (loss of blood flow) or bacterial infection.

Gemini is initially being developed for two target indications: as a pretreatment to prevent or reduce the severity of acute kidney injury (AKI) due to cardiac surgery and as a pretreatment to reduce the incidence, duration, and severity of post-surgical infection. Preclinical studies using models of AKI have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI. Additionally, preclinical studies using models of bacterial infection have demonstrated pretreatment with PHAD can reduce the overall rate and severity of infection.