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.