Revelation Biosciences Inc. Gives Oral Presentation at Advances in Critical Care Nephrology (AKI & CRRT 2024)
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The recent preclinical findings on Revelation Biosciences Inc.'s Gemini formulation, particularly in the context of acute kidney injury (AKI), are indicative of the compound's potential efficacy as a prophylactic treatment. The use of a bilateral rat model of ischemia reperfusion (I/R) is a standard approach to simulate the human condition of AKI, which is often a complication following surgeries or severe infections. The significant reductions in serum creatinine and blood urea nitrogen (BUN) levels, alongside decreased necrosis and inflammation markers, suggest that Gemini could have a substantial impact on patient outcomes if similar results are replicated in human trials.
The focus on trained immunity, through the activation of toll-like receptor 4 (TLR4) by Gemini's active ingredient PHAD®, represents an innovative approach to preventing AKI. Trained immunity refers to the long-term reprogramming of innate immune cells, which can provide a more robust response to subsequent infections or tissue damage. The upregulation of IL-10, a cytokine involved in reducing inflammation, supports the immunomodulatory potential of Gemini. This could be particularly beneficial in reducing the healthcare burden of AKI, which includes prolonged hospital stays and increased risk of chronic kidney disease.
Revelation Biosciences Inc.'s announcement concerning their proprietary formulation Gemini is likely to be scrutinized by investors, given the implications for the company's pipeline and potential market share in the AKI treatment domain. The transition from preclinical studies to a Phase 1 clinical trial and the subsequent plans to advance to patient studies within the year, highlight a significant milestone in the company's development trajectory. This progression could lead to positive investor sentiment and potential stock market movement contingent upon successful trial outcomes.
Investors will also consider the size of the market for AKI treatments, which is expected to grow due to factors such as an aging population and increased incidence of conditions that predispose individuals to AKI. A successful prophylactic treatment like Gemini could capture a significant portion of this market. However, it is essential to remain cautious, as the transition from animal models to human clinical trials often presents unforeseen challenges and positive preclinical results do not always guarantee clinical success.
The data presented on Revelation Biosciences Inc.'s Gemini could have far-reaching implications for the broader market of nephrology therapeutics. AKI remains a critical unmet medical need with limited prophylactic options. The current standard of care primarily revolves around supportive treatments, such as dialysis and optimization of fluid management, rather than prevention. Should Gemini prove effective in human trials, it could disrupt the current treatment paradigm and establish a new standard for AKI prevention.
Furthermore, the potential applicability of Gemini to other inflammatory diseases mentioned by the CEO indicates the possibility of expanding its market beyond AKI. This could open additional revenue streams for Revelation Biosciences Inc. and offer diversification of its product portfolio. Market analysts will be closely watching the progression of Gemini's clinical trials to assess its market potential and the impact it may have on the competitive landscape of nephrology therapeutics.
– Prophylactic administration of Gemini (Intravenous PHAD®) reduces tissue damage and improves kidney function in a rat model of bilateral ischemic reperfusion induced acute kidney injury (AKI) -
Results from Bilateral Rat Model of Ischemia Reperfusion Induced AKI
In a clinically relevant bilateral rat model of ischemia reperfusion (I/R) induced acute kidney injury (AKI), animals were dosed intravenously with PHAD at 0.07 or 0.35mg/kg at 24 hours and/or 48 hours prior to I/R surgery. In addition to clinical observation, rats were evaluated for markers of kidney function at 24 and/or 72 hours post-surgery, and markers of kidney damage at 72 hours post-surgery.
In this model, Gemini pretreatment (0.35mg/kg) significantly:
- Preserved kidney function with a more rapid return to base line relative to untreated control animals, with statistically significant reductions in serum creatinine (p<0.01 at 24 hours, p<0.02 at 72 hours) and serum blood urea nitrogen (BUN) (p<0.02 at 72 hours).
- Reduced overall damage (necrosis) of the cortical (p<0.02) and medullary tubules (p<0.01) relative to the untreated group.
- Significantly reduced markers of local inflammation at 24 and/or 72 hours as measured by concentrations of urinary and serum c-reactive protein (CRP) (p<0.01) and IL-6 (p<0.05).
- Significantly reduced markers of cellular inflammation as observed via reduced neutrophilic inflammation with a single dose of 0.35mg/kg (p<0.02).
The improved kidney function, reduced necrosis and reduced inflammatory biomarkers observed in this study are attributed to the immunostimulatory preconditioning effect of Gemini which includes strong upregulation of IL-10, a key cytokine responsible for resolution of inflammation.
“These results demonstrate that Gemini has the potential to reduce tissue damage and improve kidney function in ischemic reperfusion induced acute kidney injury and potentially other inflammatory diseases,” said James Rolke, Chief Executive Officer of Revelation. “In addition to this, we are excited to have initiated our Phase 1 clinical study with Gemini in February 2024 and we look forward to starting studies in patients later this year.”
About Gemini
Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program), and as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications.
About Revelation Biosciences Inc.
Revelation Biosciences, Inc. is a life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including GEMINI-SSI as a prevention for post-surgical infection, GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD for the treatment of chronic kidney disease.
For more information on Revelation, please visit www.RevBiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.
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Company Contacts
Sandra Vedrick
Vice President, Investor Relations & Human Resources
Revelation Biosciences Inc.
Email: svedrick@revbiosciences.com
and
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com
Source: Revelation Biosciences Inc.
