Revelation Biosciences Inc. Announces Commencement of First in Human Phase 1 Clinical Study of Gemini
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Insights
The commencement of a Phase 1 clinical study by Revelation Biosciences Inc. for its proprietary formulation, Gemini, marks a significant milestone in the company's efforts to address unmet medical needs. Gemini, a phosphorylated hexaacyl disaccharide (PHAD®), functions as a toll-like receptor 4 (TLR4) agonist, which is a novel approach in the field of immunotherapy. The stimulation of TLR4 is hypothesized to precondition the innate immune system, potentially offering a prophylactic benefit against acute kidney injury (AKI) and post-surgical infections.
From a research perspective, the focus on AKI is particularly notable. AKI is a condition that can lead to increased morbidity and mortality, especially in patients with comorbid conditions such as diabetes. The absence of approved therapies for AKI prevention highlights the potential market opportunity for Gemini. If the Phase 1 study yields positive results in terms of safety and biomarker activity, it could pave the way for accelerated development and fill a significant gap in the current treatment landscape.
Revelation's strategy to target both prevention of AKI and reduction of post-surgical infections addresses two areas with substantial clinical demand and economic impact. The development of Gemini could lead to a reduction in healthcare costs associated with these conditions, particularly in the context of cardiac surgery, where AKI is a common complication. Additionally, the potential to reduce the incidence and severity of post-surgical infections is of high relevance in the era of increasing antibiotic resistance, which is a pressing global health concern.
Investor attention should be drawn to the scalability of Gemini's application across multiple indications. The versatility of a TLR4 agonist in trained immunity suggests a broad therapeutic potential beyond the initial target indications. This could result in a diversified portfolio for Revelation Biosciences, potentially enhancing its market position and providing a competitive edge in the biopharmaceutical sector.
The initiation of this clinical trial is likely to be closely monitored by investors, as clinical milestones often serve as value inflection points for biotech companies. Revelation Biosciences' stock performance may be influenced by the anticipation of top-line data expected this summer. Positive data could lead to increased investor confidence and potential partnerships or funding opportunities. Conversely, any setbacks in the trial could negatively affect the company's valuation.
Long-term, the success of Gemini could have a significant impact on Revelation's revenue streams and market capitalization. However, it's crucial to note that the journey from Phase 1 to market approval is fraught with risk and the majority of compounds fail to reach commercialization. Investors should consider the inherent risks of drug development in their assessments, including the potential for adverse safety findings or lack of efficacy.
-Top-line data including safety, tolerability, and biomarker activity anticipated this summer-
-This Phase 1 clinical study data will support further development across multiple indications-
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.
“AKI is a significant and increasingly frequent health problem, especially in patients with co-morbidities such as diabetes. There are no approved therapies for preventing AKI.” said James Rolke, Chief Executive Officer of Revelation. “In addition, post-surgical infections and the continuous emergence of global antibiotic resistance necessitates the need for new therapies including those that can prevent infection. The start of this study is an important step toward bringing a potential new therapy for these unmet needs.”
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), 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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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.
FAQ
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