Revelation Biosciences (NASDAQ:REVB) announced that the FDA has accepted its investigational new drug (IND) application for Gemini in chronic kidney disease (CKD).
The company notes that the milestone enables the launch its Phase 1b clinical trial to evaluate Gemini as a preconditioning treatment in patients with CKD. The multi-site, placebo-controlled Phase 1b clinical study will enroll up to 40 subjects across 5 cohorts. The primary endpoint will evaluate the safety and tolerability of a single dose of Gemini in patients with CKD. Secondary and exploratory endpoints will assess the pharmacokinetics and Gemini’s potential to mobilize and attenuate the innate immune response to stress by measuring several predictive biomarkers of efficacy.
“We are proud to receive acceptance of our IND for Gemini, marking our most important milestone to date for Revelation,” said James Rolke, 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.”
