Company: REVB
Filing Date: 2025-05-23
Form Type: S-1/A
Source: 0001213900-25-047104
Chunk: 105

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-23
Form: S-1/A
Chunk 105
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 the outer medulla from TUNEL stained sections Day 3 after injury. N = 6-7. Source: Hernandez A, Patil N, et. al. Pretreatment with a novel Toll-like receptor 4 agonist attenuates renal ischemia-reperfusion injury. American Journal of Physiology-Renal Physiology 2023 324:5, F472 – F482. Clinical Development Plan During 2024 we conducted a Phase 1 clinical study. Subsequently, safety and biomarker activity data from our Phase 1 clinical study was announced in June of 2024, showing a significant increase in anti-inflammatory cytokines including IL-1RA and IL-10. In January of 2025 we announced the start of our Phase 1b clinical study in CKD patients. The Phase 1b clinical study will support further development of Gemini-AKI. We expect data from our Phase 1b clinic study in the first half of this year. The Phase 1b study in CKD patients will be followed by a Phase 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-inflammatory state 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-inflammatory and anti-fibrotic effects 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-day period. 65 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)