Revelation Biosciences recently announced that the US Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for Gemini. The company referred to this acceptance as a “game changing milestone” that it hopes will allow Revelation Biosciences to initiate its US-based Phase 1b clinical study to evaluate the potential of Gemini as a preconditioning treatment in patients with chronic kidney disease (CKD).
Gemini is an intravenously administrated, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD) that is intended to reduce the damage associated with inflammation by reprograming the innate immune system to respond to stress in an attenuated manner. Revelation has conducted multiple pre-clinical studies demonstrating the therapeutic potential of Gemini in the target indications. Earlier this year, Revelation announced positive Phase 1 clinical data for intravenous treatment with Gemini. The primary safety endpoint was met in the Phase 1 study, and results demonstrated statistically significant pharmacodynamic activity as observed through expected changes in multiple biomarkers including upregulation of Interleukin-10 (IL-10).
The multi-site, placebo-controlled Phase 1b clinical study will enrol up to 40 subjects in up to five cohorts. The primary endpoint is evaluation of the safety and tolerability of a single dose of Gemini in patients with CKD. Secondary and exploratory endpoints will assess the pharmacokinetics, and the potential of Gemini to mobilise and attenuate the innate immune response to stress by measuring several predictive biomarkers of efficacy.
Positive data from the Phase 1b study will enable a Phase 2 study of Gemini as a preconditioning treatment in patients with CKD to reduce the incidence, duration, and severity of acute kidney injury (AKI) in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery.
“We are proud to receive acceptance of our IND for Gemini, marking our most important milestone to date for Revelation,” said James Rolke, chief executive officer (CEO) of Revelation. “By leveraging the unique properties of trained immunity, we are exploring new ways to improve patient outcomes. We will continue to move swiftly to initiate our Phase 1b clinical study in the near future.”
