(RTTNews) - Revelation Biosciences, Inc. (REVB), a clinical-stage life sciences company, announced on Monday that the FDA has accepted its Investigational New Drug (IND) application for Gemini, allowing the company to begin a Phase 1b clinical study in chronic kidney disease (CKD) patients in early 2025.
Gemini is an intravenously administered formulation of phosphorylated hexaacyl disaccharide (PHAD) that aims to reprogram the innate immune system to respond to stress in a more protective manner.
The planned phase Ib placebo-controlled study will enroll up to 40 subjects and focus on evaluating the safety, tolerability, pharmacokinetics, and potential of Gemini as a preconditioning treatment in patients with chronic kidney disease.
If successful, the study will pave the way for a Phase 2 trial to assess Gemini's ability to reduce acute kidney injury (AKI) in patients undergoing cardiac surgeries.
James Rolke, CEO of Revelation Biosciences, stated, "We are excited to achieve FDA acceptance for the Gemini IND, marking a significant milestone for the company. By harnessing the power of trained immunity, we aim to explore innovative approaches to enhance patient outcomes and are quickly moving forward with the Phase 1b study."
Revelation is advancing Gemini across several indications, including the GEMINI-AKI program, which focuses on preventing or reducing the severity of acute kidney injury, the GEMINI-PSI program aimed at preventing post-surgical infections, and the GEMINI-CKD program, which targets slowing or halting the progression of chronic kidney disease.
REVB closed Friday's trading at $0.76, up 0.66%. In premarket trading today, the stock is up by 11.83% at $0.86.
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