Revelation Biosciences on track for end-of-phase 1 meeting later this year

Revelation Biosciences (REVB) announced successful submission and acceptance of the end-of-phase 1 meeting package to FDA and that the company is on track to hold the meeting later this year. The primary purpose of this meeting is to establish agency feedback and input into the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury. Revelation recently announced safety and activity data from its Phase 1b PRIME clinical study in stage 3 and 4 chronic kidney disease patients. The primary endpoint to evaluate the safety and tolerability of escalating doses of Gemini was met. In addition, the potential of Gemini to treat acute and chronic inflammatory conditions was demonstrated by significantly reducing inflammatory activity and restoring normal cellular response to stimuli at the cellular level, as measured in peripheral blood mononuclear cells isolated from patients at predose, 2, 24, and 168 hours post-dose.