San Diego-based Revelation Biosciences (Nasdaq: REVB) is preparing to launch a Phase 2/3 clinical study later this year for its proprietary drug candidate Gemini in acute kidney injury patients, marking a critical milestone for the clinical-stage biotechnology company.
Gemini, a formulation of the molecule phosphorylated hexaacyl disaccharide (PHAD), works by leveraging the innate immune system to rebalance the body’s inflammatory response. In pre-clinical and early clinical studies, the drug demonstrated the ability to reduce background inflammation in kidney disease patients while maintaining immune responsiveness.
“What we showed is that after a single-dose administration of Gemini, we basically turned down their inflammatory background back down to the normal level observed in cells from a healthy individual, while maintaining their responsiveness to a secondary stimuli,” said CEO James Rolke, as reported by the San Diego Business Journal. “That shows our drug is not immunosuppressive.”
Revelation selected Australian contract research organization Avance Clinical to assist in launching and managing the trial. The study is expected to take roughly two years to complete. If safety and efficacy targets are met, the company would have the data needed to submit Gemini to the U.S. Food and Drug Administration for approval in acute kidney injury, a condition with an estimated total addressable market of $94 billion.
The company’s staff has nearly doubled since the start of 2026 in anticipation of the trial. Revelation had $10.7 million in cash and cash equivalents as of fiscal year 2025.
Beyond acute kidney injury, Revelation plans to develop Gemini for chronic kidney disease to determine whether the drug can alter the trajectory of a patient’s disease over several months. That study will likely take longer to enroll and complete than the acute kidney injury trial.
Since 2022, Revelation has also developed Gemini for preventing healthcare-related bacterial infections following surgery, such as sepsis and urinary tract infections from catheterization, through a license agreement with Vanderbilt University. Severe burn-related infections remain a long-term target.
“I can’t emphasize enough, if we’re successful in what we’re endeavoring to do, we are going to change the paradigm of how you treat both acute and chronic inflammation,” Rolke said. “A number of diseases, both acute and chronic, are driven by dysregulated inflammation, and we correct that dysregulation.”
Revelation was founded in 2020 and entered the public market in 2022 via a $110 million reverse merger with special purpose acquisition company Petra Acquisition. The company employs 26 staff including contractors.
The upcoming trial positions Revelation within San Diego’s broader life sciences ecosystem, which has become a major driver of regional economic growth and venture investment.
