– Key Biomarker Activity Confirmed for Evaluation in Upcoming Phase 1 Study –
Revelation Biosciences Inc. (NASDAQ:REVB) (the “Company” or “Revelation”), announced today that data from recent preclinical studies of the Company’s Gemini formulation demonstrated its therapeutic potential as a preventative therapy across multiple indications including infection and acute kidney injury. Data, discussed below, highlights the significant pharmacologic activity following administration of Gemini in healthy animals. Additional nonclinical biomarker analyses are ongoing in preparation for a planned Phase 1 study to be initiated later this year. Further, Revelation intends to publish the full results of these nonclinical studies in conjunction with the upcoming data generated in the Phase 1 healthy volunteer clinical study.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231012415267/en/
Upregulation of key biomarkers were observed in both rodent and non-rodent healthy animal preclinical studies. This included a dose dependent migration of white blood cells (neutrophils, monocytes, and lymphocytes) from the blood stream post dose with a subsequent rebound at 24 hours (data for neutrophils in non-rodent model shown in the figure below, n=3-10 per dose level examined). White blood cell mobilization and activation plays an important role in the prevention and resolution of bacterial infection.
In addition to having an effect on white blood cells, Gemini produced a dose dependent increase in multiple cytokines of interest including interleukin-10 (IL-10), neutrophil gelatinase associated lipocalin (NGAL), and interleukin-6 (IL-6). Previously on February 7, 2023 the Company announced results from a preclinical study where administration of Gemini showed the protective effect of IL-10 and NGAL upregulation on the formation of kidney scar tissue in a validated preclinical model of acute and chronic kidney injury.
IL-10 is characterized as an anti-inflammatory cytokine leading to the ultimate resolution of inflammation. NGAL (and hepcidin, data previously shown) sequester iron to prevent iron-mediated reactive oxygen tissue damage associated with inflammation and bacterial propagation by reducing available iron stores necessary for bacterial growth. Initial upregulation of IL-6 is an important first step to establish trained immunity. This phenomenon is demonstrated after the administration of two doses of Gemini which resulted in an initial increase in both inflammatory (IL-6) and protective (IL-10) cytokines following a first dose. Then an attenuated response in IL-6 following a second dose at 24 hours (e.g. a smaller increase in inflammatory cytokines and a larger increase in protective cytokines). This attenuated response in IL-6 demonstrates the premise of trained immunity and supports the application of Gemini as a preconditioning treatment to prevent excessive inflammation. The potential need for two doses to impart protection against inflammation is currently being evaluated in a preclinical model of acute kidney injury.
“We are delighted with the robust response observed following Gemini administration and look forward to demonstrating a comparable response in healthy human volunteers,” said James Rolke, Chief Executive Officer of Revelation. “A strong response in the Phase 1 study will be a very good indication of the potential of Gemini to prevent and treat diseases such as hospital acquired infection, acute kidney injury, chronic kidney disease and myocarditis in patients who currently have limited options.”
