Company: REVB
Filing Date: 2025-04-04
Form Type: DRS
Source: 0001213900-25-029022
Chunk: 102

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-04-04
Form: DRS
Chunk 102
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1b study in patients undergoing cardiac surgery to establish dose and dosing regimen in preparation for Phase 2. The primary readout will be safety with exploratory endpoints to evaluate biomarkers and rate, duration, and severity of AKI. Gemini-CKD Program Overview Gemini is being evaluated as a potential therapy for preventing the progression of CKD. We believe Gemini may modulate the immune response from a pro -inflammatorystate to an anti -inflammatory(protective) state to rebalance the innate immune response and slow down or halt the progressive destruction and scarring of organ tissue, allowing the healing process to take place. Preclinical Revelation conducted a nonclinical study to evaluate the potential of Gemini to prevent kidney fibrosis due to excess inflammation. Specifically, a range of daily systemic dosing levels of Gemini were tested in a rat unilateral urethral obstruction (“UUO”) model. The UUO model is appropriate for studying the anti -inflammatoryand anti -fibroticeffects of potential new therapies for acute and chronic kidney disease as complete ureteral obstruction of one kidney results in significant inflammation and subsequent fibrosis of the obstructed kidney over a 7 -dayperiod. 64 The present study consisted of 6 groups with the following outcomes on renal cortical fibrosis as measured by detection of collagen deposition using picrosirius red stained histology sections assessed at three different sampling depths. Gemini Treatment Reduces Fibrosis in Acute and Chronic Kidney Model (UUO in Rats) Rats (n=11 -12per treatment group) were subjected to the UUO surgical procedure. Animals were administered either vehicle (Sham, UUO, and Positive control) or Gemini (doses listed are for active ingredient) on days 1 – 7 post surgery. Kidneys were harvested and analyzed at the end of the treatment period. Composite data represents the average of 3 anatomically distinct depths (10 images/depth/rat/group = ~60 – 65% of renal cortical area). Treatment with Gemini resulted in a significant dose -dependentreduction in fibrosis. The high dose group (0.9 mg/kg) reduced new collagen deposition (fibrosis) by 58% vs new collagen deposition observed in the no treatment UUO group (normalized to sham group, n=6). Gemini Antifibrotic Effects Likely Mediated by Validated Target Cytokines Gemini reduced TGF - βand increased IL -10and NGAL in a dose dependent manner.