Revelation Biosciences Completes Dosing in First Human Phase 1 Study of Gemini

Revelation Biosciences, Inc. (NASDAQ: REVB), a life sciences company focused on utilizing trained immunity for disease prevention and treatment, has announced the completion of enrollment and dosing for its first-in-human Phase 1 clinical study, RVL-HV02. Conducted in Australia, this study involved 40 healthy participants aged 18 to 55 receiving escalating doses of the company's proprietary formulation, Gemini. The forthcoming data will mainly address safety and tolerability, with exploratory endpoints assessing various biomarkers to demonstrate the stimulation of the innate immune response. Positive results from this Phase 1 study could support the further development of Gemini across various indications.

Gemini is a unique formulation of phosphorylated hexaacyl disaccharide (PHAD®), which acts as a toll-like receptor 4 (TLR4) agonist. Activation of TLR4 through PHAD may prime the innate immune system to respond more effectively to subsequent stresses such as ischemia or bacterial infections. Currently, Gemini is being explored for two primary applications: as a pretreatment to prevent or reduce the severity of acute kidney injury (AKI) resulting from cardiac surgery, and to lower the incidence, duration, and severity of post-surgical infections. Preclinical studies have indicated that pretreatment with Gemini can significantly reduce the severity and duration of AKI. Similarly, preclinical models of bacterial infection have shown that PHAD pretreatment can lessen the rate and severity of infection.

James Rolke, CEO of Revelation, expressed gratitude towards the study's investigators and participants, stating that the completion of Phase 1 enrollment is a crucial milestone in advancing Gemini to address several unmet medical needs. The company is eager to share the forthcoming top-line data on safety and immune response activity soon.

Gemini is designed for systemic administration and is being developed for various indications. These include the GEMINI-PSI program for post-surgical infection prevention, the GEMINI-AKI program for acute kidney injury prevention, and potentially as a treatment to halt or slow the progression of chronic kidney disease (CKD) under the GEMINI-CKD program. The company believes that Gemini leverages trained immunity to modulate the innate immune response to external stresses like infections or trauma. Multiple preclinical studies have demonstrated the therapeutic potential of Gemini for these indications.

Revelation Biosciences, Inc. is a clinical-stage company focused on harnessing trained immunity for disease prevention and treatment through its formulation, Gemini. The company has several ongoing programs to assess the efficacy of Gemini in preventing post-surgical infections, acute kidney injuries, and treating chronic kidney diseases.