Clinical-stage life sciences company Revelation Biosciences Inc (NASDAQ: REVB) announced on Monday that it has received FDA approval for its investigational new drug (IND) application for Gemini, paving the way for a Phase 1b clinical trial in early 2025. The study will evaluate Gemini as a preconditioning treatment for patients with chronic kidney disease (CKD).
The multi-site, placebo-controlled trial will enroll up to 40 participants across five cohorts. Primary objectives focus on the safety and tolerability of a single intravenous dose of Gemini, while secondary endpoints will explore pharmacokinetics and the therapy's ability to modulate innate immune response biomarkers.
Positive results could lead to Phase 2 trials aimed at reducing acute kidney injury (AKI) associated with coronary artery bypass graft (CABG) and cardiac valve surgery.
A proprietary PHAD formulation, Gemini reprograms the innate immune system to attenuate inflammation linked to surgical or stress-related trauma. Earlier Phase 1 studies confirmed its safety and demonstrated significant pharmacodynamic activity, including biomarker changes like IL-10 upregulation.
Gemini is being developed for multiple applications, including prevention of AKI (GEMINI-AKI), post-surgical infections (GEMINI-PSI) and CKD progression (GEMINI-CKD).
Revelation continues to advance its portfolio to address unmet medical needs through its innovative approach to trained immunity.
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