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ZyVersa Therapeutics Highlights Review Article Supporting the Need for Drug Therapies to Treat the Inflammation of Obesity in Addition to Weight Loss Drugs

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ZyVersa Therapeutics highlights a review article supporting the need for drug therapies to treat obesity-related inflammation alongside weight loss drugs. The article, published in Life journal, analyzes 345 publications on inflammasome-induced inflammation in obesity and its comorbidities. Obesity's chronic inflammation increases risks for metabolic diseases, atherosclerosis, tumors, and immune disorders. The company plans to develop Inflammasome ASC Inhibitor IC 100 as an add-on to incretin therapy, targeting multiple inflammasomes including NLRP3 and AIM2. ZyVersa aims to progress IC 100's obesity development program into phase 1 around mid-2025.

ZyVersa Therapeutics evidenzia un articolo di revisione che sostiene la necessità di terapie farmacologiche per trattare l'infiammazione correlata all'obesità insieme ai farmaci per la perdita di peso. L'articolo, pubblicato nella rivista Life, analizza 345 pubblicazioni sull'infiammazione indotta dagli inflammasomi nell'obesità e nelle sue comorbidità. L'infiammazione cronica dell'obesità aumenta i rischi per le malattie metaboliche, l'aterosclerosi, i tumori e i disturbi immunitari. L'azienda prevede di sviluppare Inflammasome ASC Inhibitor IC 100 come trattamento aggiuntivo alla terapia con incretine, mirando a molteplici inflammasomi tra cui NLRP3 e AIM2. ZyVersa punta a far avanzare il programma di sviluppo di IC 100 per l'obesità nella fase 1 intorno alla metà del 2025.

ZyVersa Therapeutics destaca un artículo de revisión que apoya la necesidad de terapias farmacológicas para tratar la inflamación relacionada con la obesidad junto a los medicamentos para la pérdida de peso. El artículo, publicado en la revista Life, analiza 345 publicaciones sobre la inflamación inducida por inflammasomas en la obesidad y sus comorbilidades. La inflamación crónica de la obesidad aumenta los riesgos de enfermedades metabólicas, aterosclerosis, tumores y trastornos inmunitarios. La compañía planea desarrollar Inflammasome ASC Inhibitor IC 100 como un complemento a la terapia con incretinas, dirigido a múltiples inflammasomas, incluidos NLRP3 y AIM2. ZyVersa pretende avanzar el programa de desarrollo de IC 100 para la obesidad a fase 1 alrededor de mediados de 2025.

ZyVersa Therapeutics는 체중 감소 약물과 함께 비만과 관련된 염증 치료를 위한 약물 치료의 필요성을 지지하는 리뷰 기사를 강조합니다. 이 기사는 Life 저널에 발표되었으며, 비만과 그 동반 질환에서 염증을 유도하는 염증소체에 관한 345개의 소논문을 분석합니다. 비만의 만성 염증은 대사 질환, 죽상동맥경화증, 종양 및 면역 장애에 대한 위험을 증가시킵니다. 이 회사는 NLRP3와 AIM2를 포함한 여러 염증소체를 목표로 하는 인크레틴 치료의 추가로 Inflammasome ASC Inhibitor IC 100을 개발할 계획입니다. ZyVersa는 2025년 중반경 IC 100의 비만 개발 프로그램을 1상 임상시험으로 진행할 예정입니다.

ZyVersa Therapeutics met en avant un article de revue soutenant la nécessité de thérapies médicamenteuses pour traiter l'inflammation liée à l'obésité, en plus des médicaments pour la perte de poids. L'article, publié dans la revue Life, analyse 345 publications concernant l'inflammation induite par les inflammasomes dans l'obésité et ses comorbidités. L'inflammation chronique de l'obésité augmente les risques de maladies métaboliques, d'athérosclérose, de tumeurs et de troubles immunitaires. L'entreprise prévoit de développer Inflammasome ASC Inhibitor IC 100 comme complément à la thérapie par incrétines, ciblant plusieurs inflammasomes, dont NLRP3 et AIM2. ZyVersa vise à progresser le programme de développement d'IC 100 pour l'obésité vers la phase 1 autour de la mi-2025.

ZyVersa Therapeutics hebt einen Übersichtsartikel hervor, der die Notwendigkeit von Medikamententherapien zur Behandlung von mit Fettleibigkeit einhergehender Entzündungen sowie von Gewichtsverlustmedikamenten unterstützt. Der Artikel, veröffentlicht in der Zeitschrift Life, analysiert 345 Publikationen zur durch Inflammasome induzierten Entzündung bei Fettleibigkeit und ihren Komorbiditäten. Die chronische Entzündung bei Fettleibigkeit erhöht die Risiken für Stoffwechselerkrankungen, Atherosklerose, Tumoren und Immunerkrankungen. Das Unternehmen plant, Inflammasome ASC Inhibitor IC 100 als Zusatz zur Incretintherapie zu entwickeln, um mehrere Inflammasome, einschließlich NLRP3 und AIM2, anzusprechen. ZyVersa strebt an, das Entwicklungsprogramm von IC 100 zur Behandlung von Fettleibigkeit um Mitte 2025 in die Phase 1 zu überführen.

Positive
  • Development of IC 100 as a novel first-in-class drug targeting multiple inflammasomes
  • Planned progression to Phase 1 trials by mid-2025
  • Strategic positioning in the growing obesity treatment market
Negative
  • Product still in early development stages with no clinical data
  • Extended timeline before potential commercialization
  • Will face competition from established weight loss drugs

Insights

The review article highlighting inflammasome-mediated inflammation in obesity represents a significant scientific foundation for ZyVersa's IC 100 development program. The key differentiator is IC 100's ability to inhibit multiple inflammasomes through ASC targeting, compared to competitors focusing solely on NLRP3 inhibition. However, several challenges remain:

  • The mid-2025 Phase 1 timeline suggests a lengthy path to market
  • No preclinical efficacy data specifically for IC 100 was presented
  • The obesity market is highly competitive with established players

While the scientific rationale is sound, investors should note that ZVSA is a micro-cap company ($2.2M) pursuing an early-stage program in a complex therapeutic area. The company will likely need significant capital to advance IC 100 through clinical development.

  • Obesity, due to its associated chronic, systemic inflammation, increases the risk for metabolic diseases, atherosclerosis, various malignant tumors, and numerous immune-mediated disorders.
  • With weight loss, less inflammation is expected, but adipose tissue inflammation can persist long after weight loss. One study showed that immediately after weight loss fat breakdown releases fatty acids triggering an increase in adipose tissue (AT) proinflammatory macrophages and inflammation. Over time, there is a gradual decline in inflammatory processes.
  • The NLRP3 inflammasome and its release of pro-inflammatory cytokines, IL-1β and IL-18, by AT macrophages is essential in development of obesity-related complications. NLRP3 inhibition in a DIO mouse model protected against cardiovascular complications and fatty liver disease.
  • Data from this review article support ZyVersa’s development of Inflammasome ASC Inhibitor IC 100 for obesity with associated comorbidities to be used as an add-on to incretin therapy.

WESTON, Fla., Oct. 29, 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, highlights data from a review article published in the peer-reviewed journal, Life. The article summarizes data from 345 publications on the role of inflammasome-induced inflammation in obesity and its comorbidities, and it reinforces the need for therapeutic options to better address the inflammation.

“Strong evidence that obesity treatment needs to go beyond weight loss and address the damaging inflammation leading to life-altering comorbidities is driving ZyVersa and other biopharma companies to invest in development of drugs to be used along with incretin therapy to treat inflammation,” said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Studies documenting the key role of inflammasomes in triggering obesity-associated inflammation led ZyVersa to focus on this area for development of Inflammasome ASC Inhibitor IC 100. We are excited about the potential of IC 100 to effectively control the inflammation of obesity. Unlike the NLRP3 inhibitors in development, IC 100 targets ASC to inhibit multiple inflammasomes, including NLRP3 and AIM2, which are associated with obesity. More importantly, IC 100 uniquely disrupts the function of ASC specks to attenuate chronic, systemic inflammation leading to obesity comorbidities. We look forward to progressing IC 100’s obesity development program into phase 1 around mid-2025.”

In the review article titled, The Interplay between Obesity and Inflammation, the authors concluded:

  • Development of adipose tissue inflammation triggers subsequent cardiovascular events and therefore represents a major reason for the treatment of obesity.
  • The interplay between obesity and inflammation is complex, involving a variety of cellular and humoral factors, and due to the complexity and particular features of the adipose tissue, the inflammation within may persist for long periods of time.
  • Macrophages are the main cellular component driving adipose tissue chronic inflammation. Modulation of macrophages and their release of proinflammatory cytokines, such as NLRP3-driven IL-Iβ and IL-18, can be a key factor in medical intervention in obese patients.
  • Understanding the pathophysiological changes in adipose tissue and the interplay with chronic inflammation can assist in the design of future studies and reveal opportunities for the development of more efficient therapies for obesity.

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 MediatorTM 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 ZyVersa's (ZVSA) main drug candidate for obesity treatment?

ZyVersa's main drug candidate for obesity treatment is Inflammasome ASC Inhibitor IC 100, designed to be used as an add-on to incretin therapy to treat obesity-related inflammation.

When will ZyVersa (ZVSA) begin Phase 1 trials for IC 100?

ZyVersa plans to progress IC 100's obesity development program into phase 1 around mid-2025.

How does ZyVersa's (ZVSA) IC 100 differ from other obesity treatments?

IC 100 uniquely targets ASC to inhibit multiple inflammasomes, including NLRP3 and AIM2, and disrupts ASC specks to reduce chronic inflammation, unlike NLRP3 inhibitors in development.

ZyVersa Therapeutics, Inc.

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