SAN DIEGO - Revelation Biosciences Inc. (NASDAQ: REVB), a clinical-stage life sciences company, announced today that its phase 1 clinical trial met its primary endpoint, confirming the safety and tolerability of escalating doses of Gemini, its proprietary immune preconditioning therapy.
The trial identified a maximum tolerated dose in healthy volunteers and observed significant, dose-dependent biomarker changes indicative of Gemini's immunostimulatory effect.
The study, conducted in Australia, involved 40 healthy individuals aged 18 to 55 and tested various doses of Gemini administered intravenously. Results showed significant increases in biomarkers related to the drug's expected pharmacology, such as interleukin-1RA, neutrophil gelatinase lipocalin, c-reactive protein, and IL-6, without inducing significant increases in serum TNF-α and IL-1β, which are associated with pro-inflammatory activity.
These biomarker changes align with prior preclinical models and suggest potential clinical efficacy for Gemini in preventing acute kidney injury (AKI) following cardiac surgery and reducing infection after surgery.
The drug's safety profile was acceptable, with adverse events like transient headaches and body aches correlating with higher doses but not resulting in significant changes in clinical safety markers or hematologic parameters.
James Rolke, CEO of Revelation, expressed confidence in the biomarker data, which supports the potential utility of Gemini as a single-dose therapy for various indications. The company plans to proceed with a phase 1b study in patients with chronic kidney disease by late 2024.
Gemini is a formulation of phosphorylated hexaacyl disaccharide (PHAD®), designed to precondition the innate immune system to better handle stress such as ischemia or bacterial infection. Revelation is exploring Gemini's use in several programs, including as a prevention for post-surgical infection, for AKI prevention, and as a treatment for chronic kidney disease.
The phase 1 trial's biomarker data analysis used two-tailed t-tests with an alpha of 0.05 to compare treated subjects with placebo, revealing statistically significant changes.
This news is based on a press release statement from Revelation Biosciences, Inc. Investors are cautioned that forward-looking statements are predictions based on current expectations and involve risks and uncertainties that could cause actual results to differ materially.
InvestingPro Insights
As Revelation Biosciences Inc. (NASDAQ: REVB) advances its proprietary immune preconditioning therapy, Gemini, the financial metrics and market sentiment surrounding the company provide a broader context for investors. With a modest market capitalization of $3.45 million, the company's financial standing reflects the challenges typical of early-stage clinical biotech firms.
Two InvestingPro Tips highlight key financial aspects for Revelation Biosciences. Firstly, the company is managing a delicate balance sheet dynamic, holding more cash than debt, which is a positive sign for liquidity. Still, it is also quickly burning through cash, a common scenario for clinical-stage companies that do not yet have a revenue-generating product on the market.
Investors should note that analysts are cautious about the company's profitability, not expecting Revelation to be profitable this year. Moreover, the valuation implies a poor free cash flow yield, which can be a concern for longer-term investment prospects.
Regarding performance, Revelation's stock has experienced a strong return over the last month, with a 15.3% price total return. This could indicate growing investor optimism following the recent clinical trial news. Yet, it is important to consider the broader performance context, as the stock has taken a significant hit over the last six months, with an 86.83% drop in price total return.
For those interested in a deeper dive into Revelation Biosciences' financial health and future prospects, InvestingPro offers a wealth of additional tips and data. With the use of coupon code PRONEWS24, investors can access these insights at a discounted rate for a yearly or biyearly Pro and Pro+ subscription. In total, there are 14 additional InvestingPro Tips available, which can provide a more comprehensive understanding of REVB's financial and market position. Visit https://www.investing.com/pro/REVB for more details.
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