Revelation Biosciences Reports the US FDA’s IND Acceptance of Gemini for Chronic Kidney Disease
Shots:
- The US FDA has accepted IND of Gemini to initiate P-Ib study for treating chronic kidney disease in early 2025
- The P-Ib trial will assess safety, tolerability & PK of a single Gemini dose in CKD patients (n=40), with biomarkers assessing its potential to modulate immune response. Positive results will lead to P-II targeting AKI reduction in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve
- Gemini is an IV form of phosphorylated hexaacyl disaccharide that reprograms the immune system to reduce inflammation from stress like surgery or infection. It is being developed to prevent acute kidney injury (GEMINI-AKI), post-surgical infections (GEMINI-PSI) & slow CKD progression (GEMINI-CKD)
Ref: Businesswire | Image: Revelation Biosciences
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