Revelation Biosciences, Inc. Completes the GMP Manufacture of Gemini Clinical Drug Supply

Rhea-AI Summary

Revelation Biosciences (NASDAQ: REVB) has completed the GMP manufacture of Gemini drug product for upcoming clinical studies in the United States. This manufacturing milestone is a key requirement for FDA's Investigational New Drug (IND) application. The current Gemini supply will support both the upcoming Phase 1b clinical trial in chronic kidney disease (CKD) patients and future Phase 2 studies. The company expects to report top-line results, including pharmacokinetic, pharmacodynamic, and safety data, in the first half of 2025.

Positive

• Successful completion of GMP manufacturing for Gemini drug product
• Manufactured supply sufficient for both Phase 1b and Phase 2 studies

Negative

• None.

Insights

Medical Research Analyst

The completion of GMP (Good Manufacturing Practice) manufacturing for Gemini represents a preliminary milestone, but with immediate impact. While this step is necessary for IND submission, several critical phases remain before commercial viability. The planned Phase 1b trial in CKD patients, with results expected in H1 2025, is still in early stages and carries significant execution risks.

For a micro-cap company ($3.1M market cap), having GMP-compliant product supply reduces near-term manufacturing uncertainty. However, investors should note that Phase 1b studies primarily focus on safety and dosing, not efficacy. The timeline to potential commercialization remains lengthy, requiring successful completion of Phase 2 and Phase 3 trials, each carrying substantial costs and clinical risks.

SAN DIEGO--(BUSINESS WIRE)-- Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage biopharmaceutical company focused on harnessing the power of trained immunity for the prevention and treatment of disease, today announced it has successfully completed the GMP manufacture of Gemini drug product to support anticipated clinical studies in the United States. GMP compliant manufacturing of Gemini is a pivotal requirement for an Investigational New Drug (IND) application with FDA. The Company intends to utilize the current supply of Gemini for the upcoming Phase 1b clinical trial in chronic kidney disease (CKD) patients as well as future Phase 2 studies.

“We are pleased to have achieved this critical milestone for the advancement of Gemini,” said James Rolke, Chief Executive Officer of Revelation. “We look forward to starting our Phase 1b study in CKD and anticipate top-line results including pharmacokinetic, pharmacodynamic, and safety data in the first half of 2025.”

About Gemini

Gemini is an intravenously administrated, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD^®) that reduces the damage associated with inflammation by reprogramming 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. Earlier this year Revelation 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/20241112208515/en/

Company Contact

Chester Zygmont, III

Chief Financial Officer

Revelation Biosciences, Inc.

Email: czygmont@revbiosciences.com

Source: Revelation Biosciences, Inc.

FAQ

When will Revelation Biosciences (REVB) report top-line results for Gemini's Phase 1b CKD trial?

Revelation Biosciences expects to report top-line results, including pharmacokinetic, pharmacodynamic, and safety data, in the first half of 2025.

What milestone did Revelation Biosciences (REVB) achieve for Gemini drug product?

Revelation Biosciences completed the GMP manufacture of Gemini drug product, a important requirement for FDA's Investigational New Drug (IND) application.

What clinical trials will Revelation Biosciences (REVB) use the new Gemini drug supply for?

The Gemini drug supply will be used for the upcoming Phase 1b clinical trial in chronic kidney disease (CKD) patients and future Phase 2 studies.