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

Revelation Biosciences Inc. (NASDAQ: REVB), a clinical-stage life sciences company, has initiated its 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). The study, which began dosing patients in mid-February, is a US-based multi-site placebo-controlled trial enrolling up to forty patients in five cohorts.

The PRIME study is designed to evaluate the safety, tolerability, and biomarkers of target activity of Gemini in CKD patients. Top-line data, including safety and biomarker results, are expected by mid-year. The study's findings will support future development in both the GEM-CKD and GEM-AKI programs.

Gemini is an intravenously administered, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD) that is intended to reduce the damage associated with inflammation by reprogramming the innate immune system to respond to stress in an attenuated manner. The PRIME study will assess key biomarkers of target activity, including attenuation of the inflammatory response, improved kidney function, and cardiovascular health.



The PRIME study design addresses the specific needs and challenges of Stage 3 and 4 CKD patients by focusing on a progressive disease state where therapeutic intervention could be most impactful. The multi-site, placebo-controlled nature of the trial strengthens its scientific validity, while the use of up to 40 patients across five cohorts allows for a more comprehensive evaluation of Gemini's safety and efficacy.

Revelation Biosciences' Chief Executive Officer, James Rolke, expressed enthusiasm about the PRIME study's commencement, stating, "We look forward to the results and plan to educate the public over the next few months on the importance of the planned biomarkers as it relates to CKD treatment and prevention of AKI."

The PRIME Phase 1b clinical study is a critical developmental milestone for Revelation Biosciences' CKD program. The study's design, utilizing five cohorts with escalating doses and incorporating up to 40 patients with Stage 3 and 4 CKD, will provide robust preliminary safety and biomarker data. The multi-site, placebo-controlled nature of the trial strengthens its scientific validity, while the focus on both Stage 3 and 4 CKD patients positions Gemini in a critical intervention window where effective treatments are desperately needed.

The global CKD treatment market represents a substantial opportunity, with the chronic kidney disease therapeutics market projected to reach $16.7 billion by 2025. Specifically targeting Stage 3 and 4 CKD patients positions Gemini in a critical intervention window where effective treatments are desperately needed. The potential dual application for both CKD and AKI creates multiple commercialization pathways, effectively expanding the total addressable market. With REVB's current market cap of $3,343,434, positive trial results could trigger significant value reassessment.

In conclusion, Revelation Biosciences' PRIME Phase 1b clinical study of Gemini in CKD patients is a significant step forward in the development of a promising new therapy for a prevalent and serious health condition. The study's design, biomarker assessments, and potential market impact make it an exciting development to watch in the life sciences sector.