ZyVersa Therapeutics Highlights Published Data Demonstrating the Potential of Inflammasome Inhibition to Protect Pancreatic Islet Beta Cells and Attenuate Progression from Obesity to Insulin Resistance and Type 2 Diabetes
ZyVersa Therapeutics (Nasdaq: ZVSA) highlights published data showing the potential of inflammasome inhibition to protect pancreatic islet beta cells and prevent progression from obesity to type 2 diabetes. Research demonstrated that inflammasome-driven inflammation severely damages pancreatic islets, leading to cell loss and metabolic dysfunction. The study showed that inflammasome NLRP3 inhibition protected pancreatic islet beta cells and improved metabolic status in obesity mouse models. This data supports ZyVersa's development of Inflammasome ASC Inhibitor IC 100 as an add-on to incretin therapy for obesity treatment, with phase 1 trials planned for mid-2025.
ZyVersa Therapeutics (Nasdaq: ZVSA) mette in evidenza dati pubblicati che mostrano il potenziale dell'inibizione dell'inflammasoma per proteggere le cellule beta delle isole pancreatiche e prevenire la progressione dall'obesità al diabete di tipo 2. La ricerca ha dimostrato che l'infiammazione indotta dall'inflammasoma danneggia gravemente le isole pancreatiche, portando a perdita cellulare e disfunzione metabolica. Lo studio ha mostrato che l'inibizione dell'inflammasoma NLRP3 ha protetto le cellule beta delle isole pancreatiche e ha migliorato lo stato metabolico nei modelli murini di obesità. Questi dati supportano lo sviluppo da parte di ZyVersa del Inibitore dell'Inflammasoma ASC IC 100 come complemento alla terapia con incretine per il trattamento dell'obesità, con sperimentazioni di fase 1 previste per metà del 2025.
ZyVersa Therapeutics (Nasdaq: ZVSA) destaca datos publicados que muestran el potencial de la inhibición del inflammasoma para proteger las células beta de los islotes pancreáticos y prevenir la progresión de la obesidad a la diabetes tipo 2. La investigación demostró que la inflamación impulsada por el inflammasoma daña severamente los islotes pancreáticos, lo que lleva a la pérdida celular y a disfunción metabólica. El estudio mostró que la inhibición del inflammasoma NLRP3 protegió las células beta de los islotes pancreáticos y mejoró el estado metabólico en modelos de ratones obesos. Estos datos respaldan el desarrollo por parte de ZyVersa del Inhibidor del Inflammasoma ASC IC 100 como complemento a la terapia con incretinas para el tratamiento de la obesidad, con ensayos de fase 1 planeados para mediados de 2025.
ZYVersa Therapeutics (Nasdaq: ZVSA)는 염증소체 억제가 췌장 섬세포 베타 세포를 보호하고 비만에서 제2형 당뇨병으로의 진행을 예방하는 잠재력을 보여주는 발표된 데이터를 강조합니다. 연구 결과, 염증소체에 의해 유발된 염증이 췌장 섬세체에 심각한 손상을 주어 세포 손실과 대사 기능 장애를 초래한다는 것이 밝혀졌습니다. 연구에서는 NLRP3 염증소체 억제가 췌장 섬세포 베타 세포를 보호하고 비만 쥐 모델에서 대사 상태를 개선한다는 것을 보여주었습니다. 이 데이터는 ZyVersa가 비만 치료를 위한 인크레틴 요법 추가로 ASC 염증소체 억제제 IC 100의 개발을 지원하며, 2025년 중반에 1상 임상을 계획하고 있습니다.
ZyVersa Therapeutics (Nasdaq: ZVSA) met en avant des données publiées montrant le potentiel de l'inhibition de l'inflammasome pour protéger les cellules bêta des îlots pancréatiques et prévenir la progression de l'obésité vers le diabète de type 2. La recherche a démontré que l'inflammation induite par l'inflammasome endommage gravement les îlots pancréatiques, entraînant une perte cellulaire et une dysfonction métabolique. L'étude a montré que l'inhibition de l'inflammasome NLRP3 protégeait les cellules bêta des îlots pancréatiques et améliorait l'état métabolique chez des modèles de souris obèses. Ces données soutiennent le développement par ZyVersa de l'inhibiteur de l'inflammasome ASC IC 100 comme complément à la thérapie par incrétines pour le traitement de l'obésité, avec des essais de phase 1 prévus pour mi-2025.
ZyVersa Therapeutics (Nasdaq: ZVSA) hebt veröffentlichte Daten hervor, die das Potenzial der Hemmung des Inflammasoms zeigen, um die Betazellen der Langerhans-Inseln zu schützen und das Fortschreiten von Fettleibigkeit zu Typ-2-Diabetes zu verhindern. Die Forschung hat gezeigt, dass durch das Inflammasom verursachte Entzündungen die Pankreasinseln schwer schädigen, was zu Zellverlust und Stoffwechselstörungen führt. Die Studie hat gezeigt, dass die Hemmung des Inflammasoms NLRP3 die Betazellen der Pankreasinseln schützte und den Stoffwechselstatus bei übergewichtigen Mausmodellen verbesserte. Diese Daten unterstützen die Entwicklung von ZyVersa des ASC Inflammasom Hemmers IC 100 als Ergänzung zur Inkretintherapie zur Behandlung von Fettleibigkeit, mit Phase-1-Studien, die für Mitte 2025 geplant sind.
- Development of IC 100 targets multiple inflammasomes (NLRP3 and AIM2) compared to single-target competitors
- Planned progression to Phase 1 trials by mid-2025 for obesity treatment program
- Product still in pre-clinical stage with no human trial data available
- Commercial launch timeline remains distant due to early development stage
Insights
The published preclinical data demonstrates promising therapeutic potential for inflammasome inhibition in obesity-related diabetes. The research shows that blocking NLRP3 inflammasome activity protected pancreatic beta cells and improved metabolic function in an obesity mouse model. This is particularly relevant for ZyVersa's IC 100, which targets multiple inflammasomes through ASC inhibition.
The company's planned advancement to Phase 1 trials by mid-2025 marks a significant milestone. However, investors should note that while the preclinical data is encouraging, the path from animal studies to successful human trials is lengthy and uncertain. The mechanism of targeting multiple inflammasomes, including both NLRP3 and AIM2, could potentially differentiate IC 100 from competitors focusing solely on NLRP3 inhibition, though this advantage remains to be proven in clinical trials.
- During obesity, inflammasome-driven inflammation results in significant loss of pancreatic islet beta cell mass, severely impairing the insulin secreting capacity of the remaining beta cells.
- Preserving pancreatic islet beta cell function is key to prevention of insulin resistance and development of type 2 diabetes.
- The published data showed that inflammasome NLRP3 inhibition was protective of pancreatic islet beta cells, restoring their function and improving metabolic status in an obesity DIO mouse model.
- Data from this article support ZyVersa’s development of Inflammasome ASC Inhibitor IC 100 for obesity and its associated comorbidities to be used as an add-on to incretin therapy.
WESTON, Fla., Nov. 05, 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 an article published in the peer-reviewed International Journal of Nanomedicine titled Small Intestinal Endocrine Cell Derived Exosomal ACE2 Protects Islet β-Cell Function by Inhibiting the Activation of NLRP3 Inflammasome and Reducing β-Cell Pyroptosis. Through investigation on how exosomes derived from gut microbiota can transport signals to remotely regulate pancreatic islet β-cell function, the researchers documented that:
- Inflammasome-driven inflammation resulted in severely damaged pancreatic islets.
- Damaged Islets demonstrated disrupted cellular arrangement and visible vascular thickening, leading to islet cell loss and metabolic dysfunction.
- Inflammasome inhibition reduced the inflammation and pancreatic islet damage, and attenuated the metabolic dysfunction.
“This data supports the potential of Inflammasome ASC Inhibitor IC 100, as a key component of obesity care when added to incretins used for weight loss. According to the International Obesity Collaborative, obesity care is about health, not weight. It consists of evidence-based options that address the comorbidities of obesity, such as diabetes, hypertension, and hyperlipidemia, and improve well-being,” said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “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 activated in obesity. More importantly, IC 100 uniquely disrupts the function of ASC specks to attenuate the chronic, systemic inflammation leading to obesity comorbidities. We look forward to progressing IC 100’s obesity development program into phase 1 around mid-2025.”
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
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