Revelation Biosciences Has Completed Dosing of its First in Human Phase 1 Clinical Study of Gemini
Revelation Biosciences (NASDAQ: REVB) has completed enrollment and dosing of its first-in-human Phase 1 clinical study (RVL-HV02) for Gemini, conducted in Australia.
The study evaluated escalating doses of intravenously administered Gemini in 40 healthy individuals aged 18-55. The forthcoming top-line data will assess safety and tolerability, along with biomarkers to demonstrate immune response stimulation.
Positive data could support Gemini's future development for multiple indications, including reducing acute kidney injury and post-surgical infections.
Preclinical studies have shown promising results in reducing AKI severity and bacterial infections.
Revelation's CEO, James Rolke, highlighted the milestone's significance for addressing critical unmet needs.
- Completion of Phase 1 enrollment and dosing.
- Potential for future program development across multiple indications.
- Preclinical studies indicate effectiveness in reducing AKI severity and bacterial infections.
- Focus on critical unmet medical needs like acute kidney injury and post-surgical infections.
- Forthcoming top-line data to include safety and tolerability assessments.
- No immediate financial gains or commercial products from the Phase 1 study.
- Dependence on forthcoming data for further development.
- Initial study conducted on a sample of 40 individuals.
- Potential risks and uncertainties in subsequent clinical phases.
Insights
Understanding the Clinical Study: The completion of dosing in Revelation Biosciences' Phase 1 clinical trial is a significant step. This trial focused on evaluating the safety and tolerability of Gemini, a formulation aimed to stimulate the body's innate immune response. Phase 1 typically serves to ensure that the drug is safe for humans. The next step will involve analyzing the data for potential biomarkers that could indicate efficacy.
Implications for Gemini: If the safety and tolerability data are positive, it could pave the way for more advanced clinical trials. The ability of Gemini to precondition the immune system could have broad applications, especially in acute conditions like kidney injury and post-surgical infections. Investors should keep an eye on the forthcoming data, as positive results could significantly boost the company's development pipeline and market valuation.
Rating: 1 (Positive)
Financial Considerations: For a company like Revelation Biosciences, successful progression through clinical trials can have a substantial impact on stock performance. Positive Phase 1 results could attract more investor interest and potentially lead to additional financing opportunities or partnerships. Conversely, negative results could have a detrimental impact on stock price and market confidence.
Market Potential: The applications of Gemini in preventing acute kidney injury and reducing post-surgical infections address significant medical needs. The potential market for such treatments is substantial. If Gemini proves effective, it could position Revelation Biosciences as a key player in these therapeutic areas, leading to long-term financial benefits.
Rating: 1 (Positive)
Medical Impact: The use of a TLR4 agonist like PHAD to precondition the immune system represents an innovative approach in medical science. The ability of Gemini to stimulate the innate immune response could offer a new method for preventing complications associated with surgeries. This is particularly relevant for conditions where quick immune response is crucial, such as in oncology for preventing infections during chemotherapy-induced immunosuppression.
Future Prospects: While this trial marks an initial stage, the results could have broader implications. If the technology proves effective, it may be applicable to a range of immune-related conditions, potentially opening new therapeutic avenues. Medical professionals will be keenly interested in the biomarker data to understand the scope of Gemini's effectiveness.
Rating: 1 (Positive)
-Top-line data forthcoming-
Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with PHAD potentially preconditions the innate immune system to respond to a subsequent stress, such as ischemia (loss of blood flow) or bacterial infection. Gemini is initially being developed for two target indications: as a pretreatment to prevent or reduce the severity of acute kidney injury (AKI) due to cardiac surgery and as a pretreatment to reduce the incidence, duration, and severity of post-surgical infection. Preclinical studies using models of AKI have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI. Additionally, preclinical studies using models of bacterial infection have demonstrated pretreatment with PHAD can reduce the overall rate and severity of infection.
“We are grateful to our investigator and the participants who enrolled in this study,” said James Rolke, Chief Executive Officer of Revelation. “Completion of our Phase 1 enrollment is a significant milestone for the advancement of Gemini to address multiple critical unmet needs, and we are looking forward to announcing the forthcoming topline safety and activity data soon.”
For more information on Revelation, please visit www.RevBiosciences.com.
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-PSI program), 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 clinical stage 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 as a prevention for post-surgical infection, as a prevention for acute kidney injury, and 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240613954056/en/
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.
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