-Top-line data including safety, tolerability, and biomarker activity anticipated this summer-
-This Phase 1 clinical study data will support further development across multiple indications-
SAN DIEGO, CA, USA I March 04, 2024 I Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”) a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today that it has commenced a first in human Phase 1 clinical study (RVL-HV02) to evaluate escalating doses of intravenously administered Gemini. The study is being conducted in Australia and is enrolling healthy individuals 18 to 55 years of age. Top-line data including safety, tolerability, and biomarkers of target activity are expected this summer. Data from this Phase 1 clinical study will support future development across multiple indications.
Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with PHAD potentially preconditions the innate immune system to respond to a subsequent stress, such as ischemia (loss of blood flow) or bacterial infection. Gemini is initially being developed for two target indications: as a pretreatment to prevent or reduce the severity of acute kidney injury (AKI) due to cardiac surgery and as a pretreatment to reduce the incidence, duration, and severity of post-surgical infection. Preclinical studies using models of AKI have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI. Additionally, preclinical studies using models of bacterial infection have demonstrated pretreatment with PHAD can reduce the overall rate and severity of infection.
“AKI is a significant and increasingly frequent health problem, especially in patients with co-morbidities such as diabetes. There are no approved therapies for preventing AKI.” said James Rolke, Chief Executive Officer of Revelation. “In addition, post-surgical infections and the continuous emergence of global antibiotic resistance necessitates the need for new therapies including those that can prevent infection. The start of this study is an important step toward bringing a potential new therapy for these unmet needs.”
About Gemini
Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program), as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications.
About Revelation Biosciences Inc.
Revelation Biosciences, Inc. is a life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including GEMINI-SSI as a prevention for post-surgical infection, GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD for the treatment of chronic kidney disease.
For more information on Revelation, please visit www.RevBiosciences.com.
SOURCE: Revelation Biosciences
Post Views: 666
-Top-line data including safety, tolerability, and biomarker activity anticipated this summer-
-This Phase 1 clinical study data will support further development across multiple indications-
SAN DIEGO, CA, USA I March 04, 2024 I Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”) a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today that it has commenced a first in human Phase 1 clinical study (RVL-HV02) to evaluate escalating doses of intravenously administered Gemini. The study is being conducted in Australia and is enrolling healthy individuals 18 to 55 years of age. Top-line data including safety, tolerability, and biomarkers of target activity are expected this summer. Data from this Phase 1 clinical study will support future development across multiple indications.
Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with PHAD potentially preconditions the innate immune system to respond to a subsequent stress, such as ischemia (loss of blood flow) or bacterial infection. Gemini is initially being developed for two target indications: as a pretreatment to prevent or reduce the severity of acute kidney injury (AKI) due to cardiac surgery and as a pretreatment to reduce the incidence, duration, and severity of post-surgical infection. Preclinical studies using models of AKI have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI. Additionally, preclinical studies using models of bacterial infection have demonstrated pretreatment with PHAD can reduce the overall rate and severity of infection.
“AKI is a significant and increasingly frequent health problem, especially in patients with co-morbidities such as diabetes. There are no approved therapies for preventing AKI.” said James Rolke, Chief Executive Officer of Revelation. “In addition, post-surgical infections and the continuous emergence of global antibiotic resistance necessitates the need for new therapies including those that can prevent infection. The start of this study is an important step toward bringing a potential new therapy for these unmet needs.”
About Gemini
Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program), as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications.
About Revelation Biosciences Inc.
Revelation Biosciences, Inc. is a life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including GEMINI-SSI as a prevention for post-surgical infection, GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD for the treatment of chronic kidney disease.
For more information on Revelation, please visit www.RevBiosciences.com.
SOURCE: Revelation Biosciences
Post Views: 666
