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SAN DIEGO - Revelation Biosciences, Inc. (NASDAQ:REVB), a micro-cap biotech company currently valued at $3.96 million, announced Wednesday that its drug candidate Gemini met the primary safety endpoint in a Phase 1b clinical study involving stage 3 and 4 chronic kidney disease (CKD) patients. According to InvestingPro data, the company’s stock has faced significant pressure, declining over 89% year-to-date, though analysts maintain a bullish stance with price targets ranging from $22.50 to $60.00.
The PRIME study, which enrolled 40 patients across three U.S. clinics, demonstrated that Gemini significantly reduced inflammatory activity and restored normal cellular response to stimuli in peripheral blood mononuclear cells (PBMCs) isolated from patients. While the clinical results appear promising, InvestingPro analysis indicates the company faces financial challenges with a weak overall health score of 1.57, though it maintains more cash than debt on its balance sheet.
"The activity observed with a single dose of Gemini in patients is shocking," said Principal Investigator Adam Horeish from Balboa Research, according to the company’s press release.
The study divided patients into two categories: those with minimal background inflammation and those with significant background inflammation. In patients with high background PBMC activity, Gemini reduced inflammation to levels comparable to healthy subjects and corrected the immunoparalysis typical to chronic disease.
At the target dose, adverse events were reported as mild (Grade I), including transient headache, chills, loose stool, and body aches. Three adverse events at the highest dose were reported as severe (Grade III) but resolved within three hours. No serious adverse events were reported.
The company plans to discuss advancement of the program with the FDA at an End of Phase 1 meeting later this year.
CKD affects millions worldwide and is often caused by chronic inflammation triggered by conditions such as diabetes or high blood pressure. The disease frequently progresses to end-stage renal disease requiring dialysis or transplantation.
Gemini is Revelation’s proprietary formulation of phosphorylated hexaacyl disaccharide, a toll-like receptor 4 agonist designed to rebalance the innate immune response.
The company is hosting a webcast Wednesday to discuss the study results in further detail. For investors seeking deeper insights into REVB’s financial metrics and growth potential, InvestingPro offers 13 additional exclusive tips and comprehensive analysis tools to help make informed investment decisions.
In other recent news, Revelation Biosciences, Inc. announced positive data from its Phase 1b PRIME clinical study for its kidney disease treatment, Gemini. The study, conducted on patients with stage 3 and 4 chronic kidney disease, successfully met its primary safety endpoint. It also demonstrated significant anti-inflammatory activity, with effects lasting up to seven days after a single dose. Additionally, Revelation Biosciences will implement a 1-for-3 reverse stock split on July 7, 2025. This decision follows stockholder approval at a special meeting and aims to increase the market price of the company’s common stock. The reverse split is intended to help Revelation regain compliance with Nasdaq Capital Market’s minimum bid continued listing requirements. The company’s shares will continue to trade under the symbol REVB with a new CUSIP number. These developments reflect the company’s ongoing efforts to enhance its market position and advance its clinical programs.
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