Revelation Biosciences, Inc. announced the successful completion of the Good Manufacturing Practice (GMP) manufacture of its Gemini drug product. This achievement is a pivotal requirement for the company's Investigational New Drug (IND) application with the FDA. The manufactured supply is designated to support anticipated clinical studies in the United States.
The company intends to utilize this current supply of Gemini for its upcoming Phase 1b clinical trial in chronic kidney disease (CKD) patients. Additionally, the supply will be used for future Phase 2 studies, demonstrating a forward-looking approach to its clinical development. This milestone ensures the availability of high-quality drug product for human trials.
Revelation Biosciences anticipates starting its Phase 1b study in CKD patients in the near future. Top-line results from this study, including pharmacokinetic, pharmacodynamic, and safety data, are expected in the first half of 2025. This manufacturing achievement is a critical step in advancing Gemini through the clinical development pipeline.
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