ZyVersa: IC 100 Restores Retinal Structure and Function in Retinopathy of Prematurity Model

ZyVersa Therapeutics, Inc., a biopharmaceutical company specializing in inflammatory and renal disease treatment, recently announced significant findings from researchers at the University of Miami Miller School of Medicine regarding their Inflammasome ASC Inhibitor IC 100. Published in the journal Angiogenesis, the study highlights IC 100's role in mitigating oxygen-induced retinopathy, a condition often seen in premature infants that can lead to blindness.

The research, titled “IC 100, a humanized therapeutic monoclonal anti-ASC antibody alleviates oxygen-induced retinopathy in mice,” used mouse models to simulate Retinopathy of Prematurity (ROP), a leading cause of childhood blindness worldwide. The team discovered that ASC specks, which are crucial in inflammasome activation, were significantly higher in the retinas of affected mice. These specks were found alongside abnormal blood vessels and activated microglia, indicating heightened retinal inflammation that contributes to disease progression.

Treatment with IC 100 notably decreased the expression of molecules related to inflammasomes, such as ASC and gasdermin D, as well as inflammatory cytokines like IL-1β, IL-6, and TNF, and VEGF in the retinas of the animal models. The intervention also reduced ASC speck formation and microglial activation, leading to less inflammation, abnormal vascularization, retinal thinning, and dysfunction. These structural and functional improvements were linked to the correction of gene pathways altered by hyperoxia, which are associated with eye development, leukocyte migration, angiogenesis, inflammation, neurogenesis, and VEGF signaling.

Dr. Shu Wu, Professor of Pediatrics at the University of Miami, stated, “We have demonstrated that IC 100 effectively treated both phases of oxygen-induced retinopathy in a mouse model that resembles ROP in preterm infants, as it decreased retinal vaso-obliteration and intravitreal vascularization.” He suggested that IC 100 might have therapeutic potential for preterm infants suffering from ROP.

Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President, emphasized that this research underlines the broad therapeutic potential of IC 100. He noted that ROP is the sixth condition for which preclinical data has shown IC 100 to reduce pathogenic inflammasome signaling, leading to decreased inflammation and improved outcomes. The other conditions include early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury.

IC 100 is a humanized IgG4 monoclonal antibody designed to inhibit the inflammasome adaptor protein ASC. By targeting ASC, IC 100 can mitigate the initiation and continuation of the inflammatory response. It binds to a specific region of ASC in various inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin, thus preventing the formation of inflammasomes and blocking the activation of IL-1β early in the inflammatory process. Additionally, IC 100 binds to ASC in ASC specks, further hindering the inflammatory response both inside and outside cells.

ZyVersa Therapeutics is leveraging advanced proprietary technologies to develop first-in-class drugs for patients with significant unmet medical needs due to inflammatory or kidney diseases. The company is well-positioned in the emerging inflammasome treatment space with IC 100 and in kidney disease with VAR 200, a Cholesterol Efflux Mediator™ in Phase 2 development. The lead indication for IC 100 is obesity and its associated metabolic complications, while VAR 200 is aimed at treating focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product” with the potential for numerous indications, addressing a market exceeding $100 billion.