Revelation Biosciences (NASDAQ:REVB) has announced the commencement of its PRIME Phase 1b clinical study evaluating escalating doses of Gemini, its intravenously administrated proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD), in patients with advanced chronic kidney disease (CKD).
The US-based, multi-site, placebo-controlled study aims to enroll up to 40 patients across five cohorts receiving single escalating doses. Topline data, including safety, tolerability, and biomarkers of target activity, are expected by mid-2025.
“I am delighted to see the Revelation teams’ hard work culminating with the start of the PRIME study,” James Rolke, CEO of Revelation stated. “We look forward to the results and plan to educate the public over the next few months on the importance of the planned biomarkers as it relates to CKD treatment and prevention of [acute renal failure] AKI.”
