PIPELINE

 
 
 

About Gemini

Gemini is our proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration.  It is being developed as a potential therapy for prevention and treatment of hospital acquired infection (REVTx-100 program) and as a potential treatment for acute and chronic organ disease including prevention of acute kidney injury (REVTx-300 program), myocarditis, and chronic kidney disease (CKD). Revelation believes Gemini works through the process of trained immunity, comprising redirection and attenuation of the innate immune system’s response to external stress (infection, trauma, etc.). Revelation has conducted multiple nonclinical studies demonstrating the therapeutic potential of Gemini in the target indications and plans to initiate clinical studies in 2023.

REVTx-100 

REVTx-100 is being developed, through a license agreement with Vanderbilt University, as a potential therapy for the prevention or treatment of healthcare-associated bacterial infection including post-surgical infection, post-burn infection, urinary tract infection (e.g. as a result of hospital-based or outpatient catheterization), sepsis, antibiotic-resistant infection, etc. We hypothesize stimulation of Toll like receptor-4 (TLR-4) will selectively prime the body’s immune system to be able to better respond to subsequent pathogen exposure.

Multiple preclinical studies conducted by our scientific advisors at Vanderbilt have shown that systemic pretreatment with PHAD results in significantly increased immune response leading to significantly reduced duration and severity of infection following bacterial challenge with either gram-positive or gram-negative bacteria.

Additional studies conducted by Revelation have shown that Gemini rapidly and significantly mobilizes white blood cells and key cytokines of activity in a dose dependent manner in healthy animal studies. Revelation plans to demonstrate this same rapid mobilization as part of our Phase 1 healthy volunteer clinical study. Demonstration of this phenomenon will be a good indicator of future activity in patients.

REVTx-300

REVTx-300 is being developed as a potential therapy for the treatment of acute and chronic inflammatory organ disease including acute kidney injury (AKI), chronic kidney disease (CKD) and myocarditis. We believe redirection of the innate immune response with REVTx-300 from a pro-inflammatory state to an anti-inflammatory (protective) state may rebalance the innate immune response to slow down or halt the progressive destruction and scarring of organ tissue, allowing the healing process to take place.  Preclinical studies conducted by our scientific advisors at Vanderbilt have shown that systemic pretreatment with PHAD results in significant protection from AKI and On February 7, 2023, we announced results from a preclinical study where administration of Gemini showed the protective effect of IL-10 and NGAL upregulation on the formation of kidney scar tissue in a validated preclinical model of acute and chronic kidney injury.

Additional studies conducted by Revelation have shown that Gemini can attenuate the production of inflammatory cytokines and increase the production of inflammation resolving  cytokines a dose dependent manner in healthy animal studies.  Revelation plans to demonstrate this attenuation of cytokines as part of our Phase 1 healthy volunteer clinical study. Demonstration of this phenomenon will be a good indicator of future activity in patients.