ZyVersa Therapeutics Selects Obesity and Related Metabolic Complications as Lead Indication for Inflammasome ASC Inhibitor IC 100
ZyVersa Therapeutics (ZVSA) has chosen obesity and related metabolic complications as the lead indication for its Inflammasome ASC Inhibitor IC 100. This decision is based on the growing global obesity drug market, which reached $24 billion in 2023 and is forecasted to reach up to $131 billion by 2028. Obesity affects over 40% of Americans and is associated with multiple chronic conditions, costing over $1.4 trillion annually in the US.
ZyVersa believes that IC 100, which inhibits multiple types of inflammasomes, could complement GLP-1 agonists by addressing chronic tissue inflammation not targeted by current treatments. The company plans to submit an Investigational New Drug (IND) application in Q4-2024, with Phase 1 clinical trials to follow. Preclinical collaborations are underway to assess IC 100's potential in treating atherosclerosis and obesity-related metabolic syndrome.
ZyVersa Therapeutics (ZVSA) ha scelto l'obesità e le complicanze metaboliche correlate come indicazione principale per il suo Inibitore dell'Inflamasoma ASC IC 100. Questa decisione si basa sul crescente mercato globale dei farmaci per l'obesità, che ha raggiunto i 24 miliardi di dollari nel 2023 e si prevede possa arrivare fino a 131 miliardi di dollari entro il 2028. L'obesità colpisce oltre il 40% degli americani ed è associata a diverse condizioni croniche, comportando costi superiori a 1,4 trilioni di dollari all'anno negli Stati Uniti.
ZyVersa crede che IC 100, che inibisce diversi tipi di inflamasomi, potrebbe complementare gli agonisti del GLP-1 affrontando l'infiammazione tissutale cronica non bersagliata dai trattamenti attuali. L'azienda prevede di presentare una domanda di Nuovo Farmaco Investigativo (IND) nel Q4-2024, con le successive sperimentazioni cliniche di Fase 1. Sono in corso collaborazioni precliniche per valutare il potenziale di IC 100 nel trattamento dell'aterosclerosi e della sindrome metabolica correlata all'obesità.
ZyVersa Therapeutics (ZVSA) ha elegido la obesidad y las complicaciones metabólicas relacionadas como la indicación principal para su Inhibidor del Inflamasoma ASC IC 100. Esta decisión se basa en el creciente mercado global de medicamentos para la obesidad, que alcanzó los 24 mil millones de dólares en 2023 y se prevé que llegue hasta los 131 mil millones de dólares para 2028. La obesidad afecta a más del 40% de los estadounidenses y está asociada con múltiples afecciones crónicas, costando más de 1.4 billones de dólares anuales en los EE. UU.
ZyVersa cree que IC 100, que inhibe múltiples tipos de inflamasomas, podría complementar los agonistas del GLP-1 al abordar la inflamación tisular crónica que no es objetivo de los tratamientos actuales. La compañía planea presentar una solicitud de Nuevo Medicamento en Investigación (IND) en el Q4-2024, con ensayos clínicos de Fase 1 a seguir. Se están llevando a cabo colaboraciones preclínicas para evaluar el potencial de IC 100 en el tratamiento de la aterosclerosis y el síndrome metabólico relacionado con la obesidad.
ZyVersa Therapeutics (ZVSA)는 비만 및 관련 대사 합병증을 Inflammasome ASC 억제제 IC 100의 주요 적응증으로 선택했습니다. 이 결정은 2023년 글로벌 비만 약물 시장이 240억 달러에 도달했으며, 2028년까지 1,310억 달러에 이를 것이라는 예측에 기반합니다. 비만은 미국인의 40% 이상에 영향을 미치며 여러 만성 질환과 관련이 있으며, 미국에서 연간 1.4조 달러 이상의 비용이 발생합니다.
ZyVersa는 IC 100이 여러 종류의 inflamasome을 억제하여 현재 치료법에서 목표로 하지 않는 만성 조직 염증을 해결함으로써 GLP-1 작용제와 보완할 수 있다고 믿고 있습니다. 이 회사는 2024년 4분기에 신약 연구 신청서(IND)를 제출할 계획이며, 이후에 1상 임상 시험이 이어질 것입니다. IC 100의 동맥경화증 및 비만 관련 대사 증후군 치료 가능성을 평가하기 위한 전임상 협력이 진행 중입니다.
ZyVersa Therapeutics (ZVSA) a choisi l'obésité et les complications métaboliques associées comme indication principale pour son Inhibiteur de l'Inflammasome ASC IC 100. Cette décision repose sur le marché mondial croissant des médicaments contre l'obésité, qui a atteint 24 milliards de dollars en 2023 et devrait atteindre jusqu'à 131 milliards de dollars d'ici 2028. L'obésité touche plus de 40 % des Américains et est associée à plusieurs affections chroniques, coûtant plus de 1,4 trillion de dollars par an aux États-Unis.
ZyVersa pense que IC 100, qui inhibe plusieurs types d'inflammasomes, pourrait compléter les agonistes du GLP-1 en s'attaquant à l'inflammation tissulaire chronique non ciblée par les traitements actuels. L'entreprise prévoit de soumettre une demande de Nouveau Médicament d’Essai (IND) au quatrième trimestre 2024, suivie d'essais cliniques de phase 1. Des collaborations précliniques sont en cours pour évaluer le potentiel d'IC 100 dans le traitement de l'athérosclérose et du syndrome métabolique lié à l'obésité.
ZyVersa Therapeutics (ZVSA) hat Fettleibigkeit und damit verbundene metabolische Komplikationen als die Hauptindikation für seinen Inflammasome ASC-Hemmer IC 100 ausgewählt. Diese Entscheidung basiert auf dem wachsenden globalen Markt für Medikamente gegen Fettleibigkeit, der 2023 24 Milliarden Dollar erreichte und bis 2028 auf bis zu 131 Milliarden Dollar ansteigen könnte. Fettleibigkeit betrifft über 40% der Amerikaner und ist mit zahlreichen chronischen Erkrankungen verbunden, die in den USA jährliche Kosten von über 1,4 Billionen Dollar verursachen.
ZyVersa ist der Ansicht, dass IC 100, das mehrere Arten von Inflammasomen hemmt, GLP-1-Agonisten ergänzen könnte, indem es die chronische Gewebeentzündung anspricht, die von aktuellen Behandlungen nicht angezielt wird. Das Unternehmen plant, im 4. Quartal 2024 einen Antrag auf ein neues Medikament (IND) einzureichen, gefolgt von Phase-1-Studien. Präklinische Kooperationen laufen, um das Potenzial von IC 100 zur Behandlung von Arteriosklerose und dem mit Fettleibigkeit verbundenen metabolischen Syndrom zu bewerten.
- Selection of obesity and related metabolic complications as lead indication for IC 100, tapping into a rapidly growing market
- Global obesity drug market forecasted to reach up to $131 Billion by 2028 (24 – 27% CAGR)
- IC 100 inhibits multiple types of inflammasomes, potentially offering broader efficacy than single-target treatments
- Planned IND submission in Q4-2024 with Phase 1 clinical trial initiation shortly after
- Ongoing preclinical collaborations to assess IC 100's potential in atherosclerosis and obesity-related metabolic syndrome
- IC 100 is still in preclinical stage, with no human trial data available yet
- Potential competition from established GLP-1 agonists in the obesity treatment market
- Uncertainty regarding the efficacy and safety of IC 100 in humans for obesity treatment
Insights
As a Medical Research Analyst, I find ZyVersa's decision to focus on obesity and related metabolic complications for their Inflammasome ASC Inhibitor IC 100 quite intriguing. The company's approach targets a critical aspect of obesity that current treatments, like GLP-1 agonists, don't address: chronic tissue inflammation.
The rationale behind this decision is solid. Obesity affects over 40% of Americans, with a global drug market reaching
What's particularly noteworthy is IC 100's mechanism of action. By targeting the ASC component, it inhibits multiple inflammasomes (NLRP1, NLRP3, NLRC4 and AIM2) implicated in obesity. This broad-spectrum approach could potentially offer superior inflammation control compared to more targeted therapies.
However, it's important to note that while the preclinical program is nearing completion, with IND submission planned for Q4-2024, we're still a long way from seeing clinical efficacy data. The upcoming scientific collaborations, particularly the one assessing IC 100 in combination with GLP-1 agonists, will be critical in validating this approach.
Overall, ZyVersa's strategy aligns well with the evolving understanding of obesity as an inflammatory condition. If successful, IC 100 could complement existing therapies by addressing the underlying inflammation, potentially improving outcomes for patients with obesity and related metabolic complications.
From a financial perspective, ZyVersa's pivot towards obesity and related metabolic complications for their lead compound IC 100 is a strategic move that could significantly impact the company's future valuation.
The obesity drug market's explosive growth - from
However, it's important to temper enthusiasm with caution. ZyVersa is still in the preclinical stage with IC 100, planning for IND submission in Q4-2024. This timeline puts them years away from potential market entry, during which the competitive landscape could shift dramatically.
The company's approach of targeting inflammasome inhibition as a complement to GLP-1 agonists is innovative and could carve out a unique market position. But it's also a high-risk, high-reward strategy. Success could lead to substantial returns, while failure could be costly given the resources required for clinical development.
Investors should closely monitor the upcoming preclinical collaborations and the formation of the scientific advisory board. These steps will provide important data points and expert validation of ZyVersa's approach.
In conclusion, while the potential market is undoubtedly large, ZyVersa's success will hinge on clinical results and their ability to effectively position IC 100 in an increasingly crowded obesity treatment landscape. The company's progress in the coming years will be critical in determining its long-term financial prospects.
ZyVersa's strategic shift towards obesity and related metabolic complications for their Inflammasome ASC Inhibitor IC 100 is a bold move in a rapidly evolving therapeutic landscape. This decision reflects a keen understanding of both market dynamics and unmet medical needs.
The obesity drug market's explosive growth, projected to reach
This strategy is particularly astute for several reasons:
- It targets a mechanism (inflammasome activation) that's increasingly recognized as central to obesity and its complications.
- By inhibiting multiple inflammasome types, IC 100 has the potential for broader efficacy than more targeted approaches.
- Positioning IC 100 as a complementary therapy to GLP-1 agonists could facilitate market entry and adoption.
However, ZyVersa faces significant challenges. The obesity market, while lucrative, is becoming increasingly competitive. The company will need to demonstrate clear differentiation and added value to gain traction.
The planned preclinical collaborations, particularly those assessing IC 100 in combination with GLP-1 agonists, will be crucial. Positive results could generate significant interest from both the scientific community and potential pharmaceutical partners.
In conclusion, ZyVersa's strategy is well-aligned with current trends in obesity research and treatment. However, execution will be key. The company's ability to rapidly progress through clinical development and effectively communicate the value proposition of IC 100 will determine its success in this highly promising, but challenging, therapeutic area.
WESTON, Fla., July 25, 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 that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100.
“Obesity, a well-established risk factor for an array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, and cancer, has reached pandemic proportions, affecting up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Published research demonstrating that inflammasome activation in fat tissue triggers cell death and systemic release of proinflammatory IL-1β, and ASC specks, which can perpetuate and spread inflammation leading to metabolic disturbances associated with obesity provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. We are excited about progressing our development program in this area of high unmet needs.”
Following is the rationale behind selection of obesity and related metabolic complications, and an overview of the development program.
Why Obesity and Related Metabolic Complications as an Indication?
- Large Growing Market: The global obesity drug market reached nearly
$24 billion in 2023, more than a sevenfold growth in just three years, and it is forecasted by IQVIA t to reach up to$131 Billion by 2028 (24 –27% CAGR). - Significant Health and Economic Impact: Obesity, which now affects over
40% of Americans (CDC), is associated with multiple chronic medical conditions, including type 2 diabetes, heart disease, and some forms of cancer, at an annual cost and economic impact exceeding 1.4 trillion in the United States including healthcare expenditures, loss of productivity (Milken Institute). - Need for Alternative Mechanisms of Action to Complement GLP-1 agonists: While GLIP-1 drugs deliver meaningful weight loss, improve glucose control, and help to mitigate cardiovascular disease, they do not address the chronic tissue inflammation observed in adipose tissue, liver, muscle, and pancreatic islet cells that has emerged as a key feature of obesity. This chronic tissue inflammation, termed, “immunometabolism,” leads to insulin resistance, beta cell dysfunction, and development of type 2 diabetes and long-term inflammatory complications including microvascular disease (retinopathy, nephropathy, and neuropathy), macrovascular disease (stroke, myocardial infarction, and peripheral arterial disease), heart failure, and nonalcoholic fatty liver disease. As such, anti-inflammatory drugs have potential to provide additional benefits in obesity management (Immunity. 2022 Jan 11;55(1):31-55).
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 (Front Endocrinol (Lausanne). 2023 Aug 31;14:1232171).
- 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-1β, 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 (NLRP1, NLRP3, NLRC4, and AIM2). 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 (Immunology. 2021 Aug;163(4):348-362).
- Inflammation is spread and perpetuated by systemic release of proinflammatory IL-1β 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 (Transl Res. 2022 Jul 3:S1931-5244(22)00150-5).
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 (IND) 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.
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
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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 lead indication for Inflammasome ASC Inhibitor IC 100?
When does ZyVersa (ZVSA) plan to submit an IND for IC 100?
What is the projected size of the global obesity drug market by 2028?
How does IC 100 differ from GLP-1 agonists in treating obesity?
What preclinical collaborations is ZyVersa (ZVSA) conducting for IC 100?
