ZyVersa selects obesity, related metabolic implications at lead indication

ZyVersa announces that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100. Following is the rationale behind selection of obesity and related metabolic complications, and an overview of the development program. Rationale for Inflammasome Inhibitors as a Treatment for Obesity and Related Metabolic Complications: Inflammasomes, which are activated by nutrients, such as glucose and free fatty acids, trigger activation and stimulation of downstream inflammatory pathways, leading to chronic inflammation in obesity. Nutrient overload triggers inflammasome-induced inflammation in the brain’s hypothalamus, causing increased appetite and food intake, increasing the number and size of fat cells associated with weight gain and obesity. The fat cells become hypoxic, resulting in cell death and macrophage recruitment. This leads to inflammasome activation, death of inflamed cells, and systemic release of proinflammatory cytokines, such as IL-1beta, and ASC specks, spreading inflammation throughout the body. If unresolved, sustained inflammation leads to the metabolic complications of obesity. Why Inflammasome ASC Inhibitor IC 100? Multiple types of inflammasomes, not just NLRP3, are activated in obesity and related metabolic complications. Because IC 100 targets the inflammasome ASC component, it inhibits each of these inflammasomes, including NLRP3, with potential to better attenuate the damaging inflammation associated with obesity and its complications. Inflammation is spread and perpetuated by systemic release of proinflammatory IL-1beta and ASC specks during death of inflamed cells, leading to obesity-related complications. IC 100 disrupts the structure and function of ASC specks, thereby attenuating spread and perpetuation of inflammation. ZyVersa believes that inflammasome ASC Inhibitor IC 100 administered concurrently with GLIP-1 agonists will lead to incremental weight loss, and more importantly, attenuate the chronic tissue inflammation not addressed by GLIP-1 agonists to reduce the long-term micro- and macrovascular inflammatory complications. Inflammasome ASC Inhibitor IC 100 Development Plans for Obesity and Related Complications: IC 100’s preclinical program is nearing completion, with a planned Investigational New Drug submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter. Preclinical scientific collaboration to assess IC 100 as a potential treatment for atherosclerosis, a common obesity-related metabolic complication, is expected to conclude H2-2024. Preclinical scientific collaboration with University of Miami Miller School of Medicine to assess IC 100 as a potential treatment for obesity and metabolic syndrome is expected to begin H2-2024, with a second study looking at concomitant treatment with IC 100 and a GLIP-1 agonist to begin shortly thereafter. ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board to guide clinical development plans for IC 100, which will be announced in the next few weeks.