Revelation Biosciences (NASDAQ: REVB) stock surged during intraday trading Monday after a clinical-stage life sciences company reported promising phase 1 results for Gemini.
Revelation Biosciences has announced encouraging outcomes from its phase 1 clinical trial evaluating Gemini, its immune preconditioning therapy. The trial successfully met its primary endpoint, confirming the safety and tolerability of escalating doses of Gemini in healthy volunteers.
The company conducted a study in Australia on 40 healthy individuals aged 18 to 55, administering various doses of Gemini intravenously. The trial identified a maximum tolerated dose and significant, dose-dependent changes in biomarkers associated with Gemini’s immunostimulatory effects.
The biomarker analysis highlighted substantial increases in interleukin-1RA, neutrophil gelatinase lipocalin, c-reactive protein, and IL-6 levels, aligning with the drug’s expected pharmacological effects. Importantly, the study reported no significant elevations in serum TNF-α and IL-1β, indicating controlled pro-inflammatory activity.
The trial confirmed that Gemini is well-tolerated at escalating doses. Adverse events were generally mild and transient, with reports of 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 Biosciences, expressed confidence in the trial results and the biomarker data’s implications. He highlighted Gemini’s potential as a single-dose therapy for various indications, including its application in chronic kidney disease, which will be further explored in a phase 1b study slated for late 2024.
Gemini, formulated with phosphorylated hexaacyl disaccharide (PHAD®), aims to precondition the innate immune system, enhancing its ability to manage stress like ischemia or bacterial infections.
The phase 1 trial employed rigorous statistical analysis, including two-tailed t-tests with an alpha of 0.05, confirming statistically significant biomarker changes compared to placebo-treated subjects.
Revelation Biosciences (NASDAQ: REVB) Stock Price Action
On Monday, REVB stock jumped 13.74%, closing at $2.40, marking an 8.60% increase for the week. The trading volume was 35,185,276 shares, significantly higher than the average daily volume of 610.03K.
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