ZyVersa Therapeutics Announces Published Data Supporting the Rationale for Inhibiting Inflammasome ASC with IC 100 to Control Chronic Inflammation

Rhea-AI Summary

ZyVersa Therapeutics (Nasdaq: ZVSA) has announced published data supporting the rationale for inhibiting inflammasome ASC with IC 100 to control chronic inflammation. The research, published in EMBO Molecular Medicine, demonstrates that extracellular ASC specks play a important role in the pathogenesis of amyloid A (AA) amyloidosis, a condition characterized by deposition of insoluble amyloid fibrils in tissues and organs.

Key findings include:

• ASC colocalization with SAA in human AA amyloidosis
• ASC specks accelerating SAA fibril formation
• Decreased splenic amyloid load in ASC-lacking mouse models
• Reduced amyloid loads in mice treated with anti-ASCPYD antibodies

ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes, potentially attenuating damaging inflammation in various inflammatory diseases.

Positive

• Published data supports ZyVersa's approach to inhibiting inflammasome ASC with IC 100
• Research demonstrates the important role of extracellular ASC in amyloid A amyloidosis pathogenesis
• IC 100 has potential to attenuate damaging inflammation in various inflammatory diseases

Negative

• None.

Insights

Medical Research Analyst

This research on ASC's role in amyloid A amyloidosis is a significant development for ZyVersa Therapeutics. The study provides strong scientific rationale for the company's IC 100 drug candidate, which targets ASC to inhibit inflammasome activity. Here are key implications:

• The data suggests IC 100 could potentially address a broader range of inflammatory conditions than previously thought, including rheumatoid arthritis and inflammatory bowel disease.
• By demonstrating ASC's role independent of IL-1β, the research indicates IC 100 might offer advantages over existing anti-inflammatory therapies that solely target IL-1β.
• The in vivo results showing reduced amyloid loads with anti-ASC antibodies provide a promising proof-of-concept for IC 100's potential efficacy.

While these findings are encouraging, investors should note that IC 100 is still in early-stage development and clinical trials will be important to validate these preclinical results.

Financial Analyst

This research publication represents a positive development for ZyVersa, potentially enhancing the value proposition of its IC 100 drug candidate. Key financial implications include:

• Expanded market potential: The broader applicability of IC 100 to various inflammatory conditions could significantly increase its addressable market size.
• Competitive advantage: The unique mechanism of action targeting ASC may differentiate IC 100 from existing therapies, potentially commanding premium pricing if proven effective in clinical trials.
• Increased investor interest: This scientific validation could attract more institutional investors and potential pharmaceutical partners, potentially improving ZyVersa's funding prospects.

However, investors should remain cautious as the company is still pre-revenue and will require substantial capital to advance IC 100 through clinical trials. The path to commercialization remains long and uncertain.

• Data demonstrate that extracellular ASC specks, independent of IL-1β, govern the pathogenesis and extent of amyloid A (AA) amyloidosis, which is characterized by deposition of insoluble amyloid fibrils in tissues and organs disrupting their structure and function.
• Extracellular ASC interacts with serum amyloid A (SAA) released by the liver during inflammation, forming a scaffold that accelerates SAA aggregation into amyloid fibrils, which are deposited in tissues and organs.
• Amyloid A amyloidosis occurs in a heterogeneous spectrum of chronic inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, and inflammatory bowel disease.
• ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes to attenuate damaging inflammation and its perpetuation and spread to surrounding tissues.

WESTON, Fla., Aug. 07, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces data published in the peer-reviewed journal, EMBO Molecular Medicine, demonstrating that extracellular ASC has a crucial role in aggregation and deposition of amyloid A fibrils leading to associated chronic inflammatory conditions.

“This research highlighting the role of extracellular ASC specks, independent of IL-1β, in the pathogenesis of chronic conditions associated with amyloid A amyloidosis reinforces our selection of ASC as a target for our inflammasome inhibitor IC 100,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “This paper provides one more piece of evidence that inhibiting extracellular ASC specks associated with multiple types of inflammasomes has potential to control damaging inflammation associated with a broad range of inflammatory diseases.”

The paper titled, The ASC inflammasome adapter governs SAA-derived protein aggregation in inflammatory amyloidosis, summarizes data from in vitro and in vivo research investigating the role of ASC in inflammation-associated amyloidosis. Following is a summary of key findings:

• ASC colocalized tightly with SAA in human AA amyloidosis.
• ASC specks accelerated SAA fibril formation.
• Splenic amyloid load was decreased in a Pycard knock-out mouse model of AA Amyloidosis which lacks ASC.
• Treatment with anti-ASC^PYD antibodies decreased amyloid loads in wild-type mice suffering from AA amyloidosis.

“Our findings might have therapeutic implications that advance the fields of protein misfolding disorders (PMDs) and chronic inflammatory diseases in general as ASC could be a target of disease-modifying therapies that aim to reduce amyloid deposition and pathology in various proteinopathies,” concluded the authors.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator^TM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

FAQ

What is the significance of the published data for ZyVersa Therapeutics (ZVSA)?

The published data supports ZyVersa's rationale for inhibiting inflammasome ASC with IC 100 to control chronic inflammation, particularly in conditions associated with amyloid A amyloidosis.

What is IC 100 and how does it work according to ZyVersa Therapeutics (ZVSA)?

IC 100 is an Inflammasome ASC Inhibitor being developed by ZyVersa. It inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes, potentially attenuating damaging inflammation and its spread to surrounding tissues.

What were the key findings of the research published about ZyVersa Therapeutics' (ZVSA) approach?

Key findings include ASC colocalization with SAA in human AA amyloidosis, ASC specks accelerating SAA fibril formation, decreased splenic amyloid load in ASC-lacking mouse models, and reduced amyloid loads in mice treated with anti-ASCPYD antibodies.

How might the research on ASC specks impact ZyVersa Therapeutics' (ZVSA) drug development?

The research reinforces ZyVersa's selection of ASC as a target for their inflammasome inhibitor IC 100, suggesting potential for controlling damaging inflammation associated with a broad range of inflammatory diseases.