Revelation Biosciences Doses First Patient in PRIME Phase 1b CKD Study

Revelation Biosciences, Inc., a clinical-stage life sciences company that is focused on rebalancing inflammation to optimize health, announced dosing of the first patient in the PRIME (PReconditioning IMmunostimulatory Evaluation) phase 1b clinical study of intravenous single ascending doses of Gemini in patients with Stage 3 and 4 chronic kidney disease (CKD). The US-based, multi-site, placebo-controlled study will enroll up to forty patients in up to five cohorts.

“We are excited to announce the continued advancement of Gemini with the dosing of our first patient in the PRIME study.” said James Rolke, chief executive officer of Revelation. “We look forward to a rapid enrollment and positive outcome of this study to bring Gemini one step closer to helping patients in need.”

Top-line data comprising safety, tolerability, and key biomarkers of activity including attenuation of the inflammatory response are expected by mid-year.  Data from the PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programmes.

AKI, also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in blood and makes it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also have a significant impact on other organs such as the brain, heart, and lungs.

Chronic kidney disease is a pervasive problem in the United States and world-wide. CKD is due to chronic inflammation and can be initiated and propagated in several ways. One prevalent condition is the high blood sugar levels associated with diabetes (either Type 1 or Type 2). High blood sugar is toxic to kidney cells creating stress which imitates the inflammatory process leading to the demise of these cells with subsequent fibrosis ultimately resulting in continuous loss of kidney function over time. High arterial blood pressure is another source of stress that initiates the inflammatory process leading to CKD. Other risk factors include heart disease, obesity, family history of CKD or older age. Progression of chronic kidney damage often leads to end stage renal disease with the need for renal replacement therapy (dialysis or transplantation), resulting in significant morbidity and mortality for affected patients. Kidney diseases is a leading cause of death in the United States.

Gemini is an intravenously administrated, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD) that reduces the damage associated with inflammation by reprograming the innate immune system to respond to stress (trauma, infection, etc.) in an attenuated manner. Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications.  Revelation previously announced positive phase 1 clinical data for intravenous treatment with Gemini. The primary safety endpoint was met in the phase 1 study, and results demonstrated statistically significant pharmacodynamic activity as observed through expected changes in multiple biomarkers including upregulation of IL-10.

Gemini is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI programme). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD programme).

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation Gemini.

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