– Sample analysis and data collection ongoing –
– Data expected during Q3 2025 –
SAN DIEGO--(BUSINESS WIRE)--$REVB #AKI--Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company focused on rebalancing inflammation to optimize health, today announced dosing has been completed for the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD).
As planned, a total of 5 cohorts were enrolled at 3 clinics in the United States. Several study data sets are expected during Q3 2025: these will include safety parameters, changes in hematologic parameters, in vitro evaluation of the inflammatory response in peripheral blood mononuclear cells isolated from study participants, and multiple biomarkers of activity.
“We thank our Investigators and participants for the rapid completion of dosing,” said James Rolke, Chief Executive Officer of Revelation. “We are looking forward to sharing the study data shortly, and engaging the FDA to discuss future clinical development and approval pathways later this year.”
About Gemini
Gemini is an intravenously administered, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) that reduces the damage associated with inflammation by reprograming the innate immune system to respond to stress (trauma, infection, etc.) in an attenuated manner.
Gemini is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program), or infection post severe burn (GEMINI-PBI). Gemini may also be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program).
Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. Revelation previously announced positive Phase 1 clinical data for intravenous treatment with Gemini: the primary safety endpoint was met in the Phase 1 study, and results demonstrated statistically significant pharmacodynamic activity, as observed through expected changes in multiple biomarkers including upregulation of IL-10.
About CKD
Chronic kidney disease is a pervasive problem in the United States and world-wide. CKD is caused by chronic inflammation and can be initiated and propagated in several ways. One prevalent condition is the high blood sugar levels associated with diabetes (either Type 1 or Type 2): high blood sugar is toxic to kidney cells – it creates stress, which imitates the inflammatory process, leading to the demise of these cells with subsequent fibrosis, ultimately resulting in continuous loss of kidney function over time.
High arterial blood pressure is another source of stress that initiates the inflammatory process that results in CKD. Other risk factors include heart disease, obesity, family history of CKD, or advanced age. Progression of chronic kidney damage often leads to end stage renal disease with the need for renal replacement therapy (dialysis or transplantation), resulting in significant morbidity and mortality for affected patients. Kidney disease is a leading cause of death in the United States.
About AKI
AKI, also known as acute renal failure, is a rapid loss of kidney function. AKI causes a build-up of waste products in the blood, making it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also have a significant impact on other organs, such as the brain, the heart, and the lungs.
About Revelation Biosciences, Inc.
Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on rebalancing inflammation to optimize health using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including as a prevention for post-surgical infection, for post-severe burn infection, as a prevention for acute kidney injury, and for the treatment of chronic kidney disease.
For more information on Revelation, please visit www.RevBiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.
Contacts
Mike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: mike@plrinvest.com
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com
