Company: REVB
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034584
Chunk: 76

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1
Chunk 76
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 the no treatment UUO group (normalized to sham group, n=6).

 9

Gemini Antifibrotic Effects Likely Mediated by Validated Target Cytokines

Gemini reduced TGF-β and increased IL-10 and NGAL in a dose dependent manner. TGF-β is pro-fibrotic and is directly linked to the propagation of fibrosis. The positive control is an established TGF-β blocker. IL-10 is a key driver for the reduction and resolution of inflammation, and NGAL is an important defense for preventing excessive oxidative damage resulting from injury/ongoing inflammation.

Development Plan

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.

Revelation will continue evaluating the potential of Gemini in additional preclinical models of CKD to identify optimal dosing conditions and conduct the preclinical testing required for chronic dosing in patients.

Gemini-PSI Program

Overview

Gemini is being evaluated as a potential therapy for the prevention or treatment of post surgical infection. We believe immunologic preconditioning with Gemini prepares the body to resist infection by priming the body’s immune system to respond to pathogen exposure more rapidly. In addition to post surgical infection, we believe Gemini may also have utility for post-burn infection, urinary tract infection (e.g. as a result of hospital-based or outpatient catheterization), sepsis, and antibiotic-resistant infection. Revelation is developing Gemini for the prevention of infection through a license agreement with Vanderbilt University.

Preclinical studies

Multiple preclinical studies have shown that pretreatment with PHAD results in significantly augmented immune response with significantly reduced duration and severity of infection following bacterial challenge with either gram-positive or gram-negative bacteria as indicated in the following figures.

 10

Pretreatment with PHAD Impart Protection from Gram Negative Bacterial Infection

Pretreatment with PHADs Impart Protection from Gram Positive Bacterial Infection

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. We are evaluating the next steps to be taken in the development of