Revelation Biosciences has announced the start of its PRIME—Preconditioning immunostimulatory evaluation—phase 1b clinical study, assessing escalating doses of intravenously administered Gemini in patients with stage 3 and 4 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.
The US-based multi-site placebo-controlled study will enrol up to 40 patients in five cohorts of single escalating doses.
“I am delighted to see the Revelation team’s hard work culminating with the start of the PRIME study.” said James Rolke, chief executive officer of Revelation. “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 kidney injury (AKI).”
Top-line data including safety, tolerability, and biomarkers of target activity are expected by mid-year. Data from the PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programmes.
