ZyVersa Therapeutics Chooses Obesity as Lead Indication for IC 100

ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA), a biopharmaceutical company focused on developing innovative treatments for inflammatory and renal conditions, has announced that obesity and its associated metabolic complications will be the primary focus for their Inflammasome ASC Inhibitor, IC 100. Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President, highlighted the critical need for addressing obesity, noting that it is a significant risk factor for numerous metabolic disorders such as insulin resistance, type 2 diabetes, hypertension, cardiovascular diseases, and cancer. Glover emphasized that inflammasome activation in fat tissue triggers cell death and systemic inflammation, which are key contributors to the metabolic issues linked with obesity. This underpins the potential of IC 100 as a therapeutic solution.

The global rise in obesity underscores the urgency of this development. The global market for obesity drugs skyrocketed to nearly $24 billion in 2023 and is expected to reach $131 billion by 2028. In the United States, over 40% of the population is affected by obesity, leading to multiple chronic health conditions and an economic burden exceeding $1.4 trillion annually.

While existing treatments like GLP-1 agonists have shown effectiveness in weight management and glucose control, they do not address the chronic tissue inflammation associated with obesity. This inflammation, termed "immunometabolism," leads to various long-term complications such as type 2 diabetes, heart disease, and nonalcoholic fatty liver disease. Therefore, anti-inflammatory drugs like IC 100 could provide additional benefits in managing obesity by targeting the inflammasomes responsible for chronic inflammation.

Inflammasomes are protein complexes that trigger inflammatory responses when activated by excessive nutrients like glucose and fatty acids. This activation can lead to chronic inflammation in obese individuals. Inflammasome activation in the hypothalamus can increase appetite and food intake, contributing to further weight gain. Additionally, hypoxic fat cells cause inflammasome activation, resulting in the death of these cells and the release of proinflammatory cytokines like IL-1β, which perpetuates inflammation and leads to metabolic complications.

IC 100 targets the inflammasome ASC component, thereby inhibiting multiple types of inflammasomes, including NLRP3. This broad inhibition can potentially mitigate the chronic inflammation seen in obesity and its related complications. IC 100 disrupts the structure and function of ASC specks, which are responsible for spreading inflammation, thus offering a comprehensive approach to reducing obesity-related inflammation.

ZyVersa's development program for IC 100 is advancing, with the preclinical program nearing completion. An Investigational New Drug (IND) submission is planned for the fourth quarter of 2024, followed by the initiation of Phase 1 clinical trials. Collaborations with the University of Miami Miller School of Medicine will explore the potential of IC 100 in treating obesity and metabolic syndrome, with studies on concomitant treatment with IC 100 and GLP-1 agonists set to begin shortly.

To guide the clinical development of IC 100, ZyVersa has assembled a scientific advisory board comprising six experts in obesity and related metabolic complications. Announcements regarding this advisory board will be made in the coming weeks.

IC 100 is a novel humanized IgG4 monoclonal antibody designed to inhibit the inflammasome adaptor protein ASC. By binding to the ASC component of various inflammasomes, IC 100 aims to prevent the initiation and perpetuation of inflammatory responses. This mechanism is expected to be beneficial not only for obesity but also for a range of inflammatory diseases. ZyVersa Therapeutics continues to leverage its advanced proprietary technologies to address high unmet medical needs in inflammatory and renal diseases.