ZyVersa Advances Development of Inflammasome Inhibitor Candidate

ZyVersa announced advancements in development of our lead inflammasome inhibitor candidate, IC 100. IC 100 is a novel monoclonal antibody that inhibits the ASC component of multiple types of inflammasomes, with potential to block initiation of the inflammatory cascade and attenuate inflammation in people with debilitating inflammatory diseases.

Initial preclinical studies demonstrate proof-of-concept for IC 100, with positive animal model data in multiple sclerosis, acute lung injury, spinal cord injury, traumatic brain injury, and stroke. Additional pharmacology studies are underway for diabetic nephropathy, NASH, and lupus nephritis. Likewise, an IND-enabling preclinical program has been initiated, leading to conduct of a Phase 1 clinical trial in humans in the next 18 – 24 months. ZyVersa's licensor and scientific partner, InflamaCORE, has recently signed a commercial license agreement for the IC 100 cell bank with a global leader in mammalian cell line generation, Selexis SA. Likewise, an award-winning contract manufacturer, KBI Biopharma, has been selected to produce IC 100 clinical supplies.

"We are thrilled with the progress made towards advancing IC 100 to human trials," stated Stephen Glover, Co-founder, Chief Executive Officer, and President of ZyVersa Therapeutics. "IC 100 has potential to transform treatment of debilitating inflammatory diseases by inhibiting ASC, which is a component of multiple types of inflammasomes. This is an important differentiator for IC 100 since activation of multiple inflammasomes, not just the NLRP3 inflammasome, has been shown to be pathogenic in numerous chronic inflammatory diseases."

"Our commercial license with Selexis for the IC 100 cell bank is a critical milestone for progressing IC 100 to the clinic," said Dr. Robert W. Keane, InflamaCORE's Founder, and Professor of Physiology and Biophysics, Neurological Surgery and Microbiology, and Immunology at the University of Miami, Miller School of Medicine. "It is extremely rewarding to see our 30 plus years of research on inflammasomes and the innate immune response advance toward a potential transformative treatment for debilitating inflammatory diseases."

C 100 is a monoclonal antibody that uniquely inhibits the adaptor ASC component of multiple types of inflammasomes. Because pathogenesis of numerous chronic inflammatory diseases involves activation of more than one type of inflammasome (e.g. the NLRP3 inflammasome), IC 100 may be more effective for treating a broad range of inflammatory diseases than targeting just one.

By inhibiting ASC, IC 100 blocks inflammasome formation, with potential to block initiation of the inflammatory cascade. By inhibiting the ASC component of ASC Specks, IC 100 disrupts the structure and function of ASC Specks, with potential to block perpetuation of the inflammatory response responsible for chronic, damaging inflammation.

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