On Monday, Revelation Biosciences Inc (NASDAQ:REVB) announced safety and biomarker data for its Phase 1 study (RVL-HV02).
The primary endpoint to evaluate the safety and tolerability of escalating doses of Gemini was met and a maximum tolerated dose in healthy volunteers was identified.
Additionally, statistically significant dose-dependent upregulation of key biomarkers demonstrating the immunostimulatory preconditioning effect of Gemini was observed.
The study enrolled 40 healthy individuals 18 to 55 years of age.
Administration of Gemini induced significant, dose-dependent changes in key circulatory biomarkers of activity that reflect the expected pharmacology of Gemini-specific toll-like receptor 4 (TLR4) stimulation.
Intravenous Gemini induced significant increases in interleukin-1RA (IL-1RA) (p<0.001 at mid and high dose), neutrophil gelatinase lipocalin (NGAL) (p<0.01 at mid and high dose), c-reactive protein (CRP) (p<0.001 at mid and high dose), and IL-6 (p<0.01 at high dose).
Significant, dose-dependent mobilization of innate immune cell populations was observed, specifically neutrophils (p<0.001 at mid-dose and high dose) and monocytes (p<0.001 at mid and high dose).
Gemini administration did not induce significant increases in serum TNF-α (p=0.51 at the highest dose) and IL-1β (p=0.89 at the highest dose).
Gemini administration was generally well-tolerated.
"With this new data, we are excited and committed to moving rapidly into a Phase 1b study in patients in late 2024," said James Rolke, Chief Executive Officer of Revelation.
Gemini is initially being developed as a single-dose preconditioning therapy for two target indications:
- As a pretreatment to prevent or reduce the severity of acute kidney injury due to cardiac surgery (GEMINI-AKI program).
- As a pretreatment to reduce the incidence, duration, and severity of post-surgical infection (GEMINI-PSI program).
Price Action: REVB shares are up 31.30% at $2.77 at the last check on Monday.