Revelation Biosciences Selects Avance Clinical as CRO for Phase 2/3 TITAN Study
Revelation Biosciences, Inc., a clinical-stage life sciences company focused on developing innovative therapies for acute and chronic diseases, has announced the selection of Avance Clinical as the contract research organization (CRO) for its upcoming Phase 2/3 adaptive-design TITAN clinical study. The study will evaluate Gemini, Revelation Biosciences’ investigational therapeutic candidate, in patients suffering from acute kidney injury (AKI).
The appointment of an experienced CRO represents an important milestone in preparing for a complex clinical trial. CROs play a critical role in supporting pharmaceutical and biotechnology companies throughout the development process by providing operational expertise, clinical trial management, regulatory support, data management and other essential services required to conduct studies efficiently and in accordance with applicable standards.
For the TITAN study, Avance Clinical will provide comprehensive clinical trial support, including assistance with clinical site identification and management, patient recruitment, monitoring, safety oversight and data management. These activities are essential to ensuring that clinical data are collected consistently, accurately and completely, while helping investigators and study teams maintain high standards throughout the trial.
The selection of Avance Clinical followed an extensive evaluation process by Revelation Biosciences. The company assessed potential CRO partners based on their experience, operational capabilities and ability to support the requirements of a Phase 2/3 adaptive-design clinical study. Avance Clinical’s full-service CRO capabilities and global operational presence were important factors in its selection.
The TITAN study is expected to represent a significant step in the clinical development of Gemini for patients affected by acute kidney injury, a serious medical condition characterized by a sudden decline in kidney function. AKI can occur in hospitalized and critically ill patients and may be associated with substantial clinical complications, making the development of potential new treatment approaches an important area of medical research.
James Rolke, Chief Executive Officer of Revelation Biosciences, emphasized the importance of choosing the right CRO as the company prepares to advance the TITAN program. He noted that the selection process involved a detailed assessment of potential partners and that working closely with Avance Clinical will allow the Revelation team to focus on the successful execution of the study.
As part of the collaboration, Revelation Biosciences and Avance Clinical will work together to establish the operational framework required to initiate the trial. This includes coordinating clinical sites, supporting enrollment activities, monitoring study progress and maintaining the quality and integrity of clinical data.
Revelation Biosciences remains focused on advancing Gemini through clinical development and plans to begin the Phase 2/3 TITAN study later this year. The company believes that the study could provide important clinical insights into the potential role of Gemini in treating patients with acute kidney injury.
The planned adaptive-design approach is intended to provide flexibility during the study while maintaining appropriate clinical and statistical standards. As preparations continue, the collaboration between Revelation Biosciences and Avance Clinical is expected to support the efficient implementation and management of the TITAN trial.
The selection of Avance Clinical marks another important development for Revelation Biosciences as it moves toward the next stage of clinical evaluation. With study preparation underway, the company is working toward initiating the TITAN trial and generating additional clinical evidence on Gemini’s potential in patients with acute kidney injury.
About Revelation Biosciences, Inc.
Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.
