Revelation Biosciences, Inc. has announced the start of its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The study is designed to assess the safety, tolerability, and potential therapeutic effects of Gemini, an intravenously administered formulation, in this patient population.
The PRIME study is a US-based, multi-site, placebo-controlled trial that will enroll up to forty patients. Participants will be divided into five cohorts, each receiving a single escalating dose of Gemini. Dosing is expected to commence in mid-February, with top-line data anticipated by mid-year. The data will include safety assessments, tolerability measures, and biomarker analysis to evaluate target activity.
Gemini's Mechanism of Action
Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®). It is designed to mitigate inflammation-related damage by reprogramming the innate immune system, enabling a more attenuated response to stress factors such as trauma or infection. Preclinical studies have demonstrated Gemini's therapeutic potential across various indications.
Clinical Development Programs
Revelation Biosciences is developing Gemini for multiple indications, including:
- GEMINI-AKI: Prevention or reduction of the severity and duration of acute kidney injury.
- GEMINI-PSI: Prevention or reduction of the severity and duration of post-surgical infection.
- GEMINI-CKD: Treatment to halt or slow the progression of chronic kidney disease.
Management Commentary
"I am delighted to see the Revelation teams’ hard work culminating with the start of the PRIME study," said James Rolke, Chief Executive Officer of Revelation. "We look forward to the results and plan to educate the public over the next few months on the importance of the planned biomarkers as it relates to CKD treatment and prevention of AKI."
About Chronic Kidney Disease (CKD)
Chronic kidney disease is characterized by chronic inflammation, often initiated and propagated by conditions such as high blood sugar levels associated with diabetes or high arterial blood pressure. These factors can damage kidney cells, leading to fibrosis and a progressive loss of kidney function. CKD is a significant health concern worldwide, often progressing to end-stage renal disease requiring dialysis or transplantation.
