Revelation Biosciences Doses First Patient in PRIME Phase 1b Clinical Study of Gemini in CKD Patients

Rhea-AI Summary

Revelation Biosciences (NASDAQ: REVB) has initiated patient dosing in its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of Gemini. The study focuses on evaluating intravenous single ascending doses in patients with Stage 3 and 4 Chronic Kidney Disease (CKD).

The US-based, multi-site, placebo-controlled trial will include up to forty patients across five cohorts. The company expects to release top-line data by mid-year, which will assess safety, tolerability, and key biomarkers of activity, including attenuation of the inflammatory response. Results from this PRIME study will support future development of both GEM-CKD and GEM-AKI programs.

Positive

• First patient dosed in Phase 1b trial
• Study progressing on schedule with mid-year data expected
• Multi-site US-based trial increases study credibility

Negative

• Early-stage Phase 1b trial with no efficacy data yet
• Small study size of only 40 patients

Insights

Financial Analyst

Revelation Biosciences has initiated patient dosing in its PRIME Phase 1b study of Gemini for Chronic Kidney Disease (CKD), representing a significant clinical milestone for this $2.2 million market cap company. The placebo-controlled study will evaluate intravenous single ascending doses in up to 40 patients with Stage 3-4 CKD across multiple U.S. sites.

Gemini's approach of "rebalancing inflammation" rather than simply suppressing it differentiates it from conventional treatments. This is particularly relevant in CKD, where chronic inflammation drives disease progression and existing treatments primarily address symptoms rather than underlying inflammatory mechanisms. The CKD market represents a substantial opportunity, with approximately 37 million Americans affected and global treatment costs exceeding $120 billion annually.

The expected mid-year 2025 data readout will focus on safety, tolerability, and inflammatory biomarkers. While primarily a safety study, positive biomarker data could validate Gemini's mechanism and support advancement to efficacy-focused trials. This data will inform two development pathways: chronic (GEM-CKD) and acute kidney injury (GEM-AKI), potentially expanding Gemini's market reach.

For investors, key considerations include: 1) Revelation's cash runway to support completion of this study and potential Phase 2 trials, 2) enrollment pace which could affect the timeline for data readout, and 3) the competitive landscape of inflammation-targeting therapies in nephrology. The small market capitalization suggests significant upside potential if data is positive, though also reflects the early-stage risk profile typical of clinical-stage biotechs.

– Topline data expected Mid-Year –

SAN DIEGO--(BUSINESS WIRE)-- Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on rebalancing inflammation to optimize health, announced dosing of the first patient in the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of intravenous single ascending doses of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The US-based, multi-site, placebo-controlled study will enroll up to forty patients in up to five cohorts.

“We are excited to announce the continued advancement of Gemini with the dosing of our first patient in the PRIME study,” said James Rolke, Chief Executive Officer of Revelation. “We look forward to a rapid enrollment and positive outcome of this study to bring Gemini one step closer to helping patients in need.”

Top-line data comprising safety, tolerability, and key biomarkers of activity including attenuation of the inflammatory response are expected by mid-year. Data from the PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programs.

About AKI

AKI, also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in blood and makes 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, heart, and lungs.

About CKD

Chronic kidney disease is a pervasive problem in the United States and world-wide. CKD is due to 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 creating 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 leading to CKD. Other risk factors include heart disease, obesity, family history of CKD or older 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 diseases is a leading cause of death in the United States.

About Gemini

Gemini is an intravenously administrated, 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. 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.

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). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program).

About Revelation Biosciences, Inc.

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including as a prevention for post-surgical 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250226010762/en/

Company 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

Source: Revelation Biosciences, Inc.

FAQ

What is the primary objective of REVB's PRIME Phase 1b clinical study for Gemini?

The study evaluates safety, tolerability, and inflammatory response biomarkers of intravenous single ascending doses of Gemini in Stage 3 and 4 Chronic Kidney Disease patients.

How many patients will be enrolled in Revelation Biosciences' PRIME study for CKD?

The study will enroll up to 40 patients across five cohorts.

When will REVB release the topline data for the Gemini PRIME study?

Topline data is expected to be released by mid-year.

What are the future applications of the PRIME study data for REVB?

The data will support future development of both the GEM-CKD and GEM-AKI programs.