Revelation Biosciences Inc. announced that recently completed exploratory biomarker analysis has confirmed clinical development plans for REVTx-300 in the treatment of CKD and AKI. This new biomarker data is in addition to the previously-announced significant reduction in new collagen deposition (57%) observed in a preclinical fibrosis model and provides the potential for new intellectual property. Reduction in new collagen deposition (fibrosis) helps maintain kidney function.

Fibrosis or scarring, results in loss of normal kidney function. Loss of normal kidney function causes the build-up of toxic materials which leads to further deleterious health effects, propagation of chronic disease, and ultimately, death. During the first half of 2023 Revelation plans to initiate a Phase 1a clinical study comprising 5 cohorts of single ascending doses and a 6th cohort of multiple doses of REVTx-300 to investigate safety and drug activity.

Revelation plans to initiate a Phase 1b clinical study in patients undergoing elective cardiac surgery in the second half of 2023. Revelation originally announced on October 25, 2022 positive results from the preclinical model of acute kidney injury and chronic kidney disease. Additional analysis found that treatment with REVTx-300 significantly reduced new collagen deposition (fibrosis) in the renal cortex in a dose dependent manner in the medium and high dose groups (42.1% reduction (p <0.05) and 56.7% (p < 0.05), respectively).

The reduction in new collagen formation was calculated for each treatment group vs the unilateral ureteral obstruction (UUO) control group after correction for the normal collagen levels observed in the sham control. In addition to the reduction in new collagen deposition, treatment with REVTx-300 had no significant effect on body weight or kidney weight when compared to the UUO control group animals. REVTx-300 had minimal impact on hydroxyproline content in the renal cortex in a non-dose dependent manner when compared to the UUO control group.

The UUO model is appropriate for studying the anti-inflammatory and anti-fibrotic effects of potential new therapies for acute and chronic kidney disease as complete ureteral obstruction of one kidney results in significant inflammation and subsequent fibrosis of the affected kidney over a 7-day period. About REVTx-300: REVTx-300 is proprietary formulation for systemic administration of PHAD and is being developed as a potential therapy for the treatment of acute and chronic organ disease including chronic kidney disease (CKD), acute kidney injury (AKI), myocarditis, and nonalcoholic steatohepatitis (NASH). Chronic disease of an organ, due to chronic inflammation and subsequent fibrosis, follows a pattern of perpetual and ongoing destruction of living functional cells and subsequent replacement by the non-functional protein, collagen, resulting in fibrosis (scar tissue).

The establishment of fibrosis and subsequent death of the organ is driven by chronic inflammatory processes and reactive oxygen species mediated by the innate immune response.