SAN DIEGO, CA — January 21, 2026 — Leads & Copy — Revelation Biosciences, Inc. (NASDAQ:REVB) has reached an agreement with the FDA regarding the approval pathway for Gemini as a treatment for Acute Kidney Injury (AKI).
The agreement specifies that positive data from a single well-controlled Phase 2/3 adaptive design clinical study, involving approximately 300 patients, and a clinically relevant and objective composite endpoint comprising death and/or need for dialysis would be sufficient for submission of a new drug application (NDA).
James Rolke, Chief Executive Officer of Revelation, expressed gratitude for the FDA’s collaborative feedback on the Gemini program, stating that it provides a clear path forward for seeking approval of Gemini as an AKI treatment. Rolke added that the Revelation team will remain focused on completing the activities required for the successful execution of the pivotal study.
The advantage of the adaptive design Phase 2/3 study is the ability to transition rapidly from Phase 2 to Phase 3, with an opportunity to sufficiently power the Phase 3 portion of the study.
The planned adaptive Phase 2/3 design will be a randomized, double-blind, placebo-controlled study, and will be comprised of two parts. Part 1 will evaluate different dosing regimens vs placebo and part 2 will be conducted as a Phase 3 study using the safest dosing regimen identified in part 1. Data from both part 1 and part 2 can be used in the primary and secondary endpoint analyses. The primary endpoint will be a composite of measures including death and/or the need for dialysis.
According to the American Hospital Association, approximately 34 million people are admitted to US hospitals each year. The University of Florida found that 20%, or approximately 6.8 million, of these patients had AKI. The CDC reports that Medicare’s annual expenditure for AKI in 2015 alone was over $10 billion and growing, with AKI-related costs of approximately $42,077 per patient.
Revelation will continue to build the infrastructure required to successfully conduct this clinical study over the course of 2026, including engaging a clinical research organization specializing in hospital-based renal studies, establishing an expert panel of scientific advisors, and completing the manufacture of clinical drug supply. Revelation is working expeditiously toward initiating the Phase 2/3 study.
Gemini is Revelation’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI), chronic kidney disease (GEM-CKD), to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and to prevent post-surgical infection (GEM-PSI).
AKI, also known as acute renal failure, is defined as a rapid loss of kidney function, causing a build-up of waste products in blood and making it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also significantly impact other organs such as the brain, heart, and lungs. Severe AKI requiring dialysis significantly increases the likelihood of worse outcomes including longer time in an ICU, potential to develop chronic kidney disease, and death.
AKI affects more than 10% of all hospitalized patients and more than 50% of patients admitted to intensive care units. Dialysis is still the only therapeutic option in the treatment of the consequences of severe AKI and is required in approximately 20% of all critically ill patients.
Mike Porter
Investor Relations
Porter LaVay & Rose Inc.
Email: mike@plrinvest.com
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com
Source: Revelation Biosciences, Inc.
