Revelation Biosciences Gets FDA Nod for Gemini IND

Revelation Biosciences, Inc. (NASDAQ: REVB), a clinical-stage life sciences company focused on utilizing trained immunity for disease treatment, has announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for Gemini. This approval allows the company to begin a Phase 1b clinical trial in the United States to evaluate Gemini as a preconditioning treatment for patients with chronic kidney disease (CKD).

This placebo-controlled Phase 1b clinical study will take place at multiple sites and will include up to 40 participants, divided into five cohorts. The primary goal of the study is to assess the safety and tolerability of a single dose of Gemini in CKD patients. Secondary and exploratory objectives will include evaluating the pharmacokinetics of Gemini and its ability to mobilize and moderate the innate immune response to stress by measuring several biomarkers that predict efficacy.

Positive outcomes from this Phase 1b study could pave the way for a Phase 2 trial. The aim of the subsequent trial would be to use Gemini as a preconditioning treatment in CKD patients to reduce the incidence, duration, and severity of acute kidney injury (AKI) in those undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery.

Revelation's Chief Executive Officer, James Rolke, expressed pride over the IND acceptance, highlighting it as a significant milestone for the company. By exploring the unique properties of trained immunity, Revelation is seeking new methods to enhance patient outcomes. The company plans to proceed swiftly with the Phase 1b clinical trial.

Gemini is an intravenously administered, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®). It aims to reduce inflammation damage by reprogramming the innate immune system to respond less aggressively to stressors such as surgery, trauma, and infection. Revelation has previously conducted multiple preclinical studies that demonstrated Gemini’s therapeutic potential in its target indications. Earlier this year, the company announced positive Phase 1 clinical data for intravenous treatment with Gemini, having met the primary safety endpoint. The results showed statistically significant pharmacodynamic activity, notably through changes in multiple biomarkers, including the upregulation of IL-10.

Gemini is being developed for various applications. The GEMINI-AKI program focuses on preventing or reducing the severity and duration of acute kidney injury. The GEMINI-PSI program aims to prevent or reduce the severity and duration of post-surgical infections. Additionally, the GEMINI-CKD program explores Gemini's potential to halt or slow the progression of chronic kidney disease.

Revelation Biosciences, Inc. is dedicated to harnessing the power of trained immunity to prevent and treat diseases using its proprietary formulation, Gemini. The company has multiple ongoing programs to evaluate Gemini’s effectiveness, including its use in preventing acute kidney injury, post-surgical infections, and treating chronic kidney disease.