ZyVersa Therapeutics Announces Published Data Showing Inflammasome ASC Inhibitor IC 100 Decreases Microglial Inflammasome Activation and Alpha-Synuclein That Contribute to Neurodegeneration in Parkinson’s Disease
ZyVersa Therapeutics announces breakthrough data for their Inflammasome ASC Inhibitor IC 100 in treating Parkinson's Disease (PD). The study, published in npj Parkinson's Disease and supported by the Michael J. Fox Foundation, shows IC 100's potential to slow PD progression.
Key findings demonstrate that IC 100 effectively blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation - two major factors in PD progression. The research, conducted at the University of Miami Miller School of Medicine, reveals the first evidence linking ASC speck assembly, NLRP1 inflammasome activation, and alpha-synuclein aggregation in PD patients' neurons.
The global PD drug market, valued at $6.6 billion in 2024, is projected to reach $13.3 billion by 2034. Unlike current treatments that only address symptoms, IC 100 shows promise as a disease-modifying therapy. ZyVersa plans to begin proof-of-concept animal studies later this year.
ZyVersa Therapeutics annuncia dati rivoluzionari per il loro Inibitore dell'Inflammasoma ASC IC 100 nel trattamento del Morbo di Parkinson (PD). Lo studio, pubblicato su npj Parkinson's Disease e supportato dalla Michael J. Fox Foundation, evidenzia il potenziale di IC 100 nel rallentare la progressione del PD.
I risultati chiave mostrano che IC 100 blocca efficacemente l'attivazione dell'inflammasoma microgliale e riduce l'accumulo neurotossico di alfa-sinucleina, due fattori principali nella progressione del PD. La ricerca, condotta presso la University of Miami Miller School of Medicine, rivela la prima evidenza che collega l'assemblaggio di ASC speck, l'attivazione dell'inflammasoma NLRP1 e l'aggregazione di alfa-sinucleina nei neuroni dei pazienti con PD.
Il mercato globale dei farmaci per il PD, valutato 6,6 miliardi di dollari nel 2024, è previsto raggiungere 13,3 miliardi entro il 2034. A differenza dei trattamenti attuali che si limitano a gestire i sintomi, IC 100 mostra potenzialità come terapia modificante la malattia. ZyVersa prevede di avviare studi proof-of-concept su animali entro la fine dell'anno.
ZyVersa Therapeutics anuncia datos innovadores para su Inhibidor del Inflammasoma ASC IC 100 en el tratamiento de la Enfermedad de Parkinson (PD). El estudio, publicado en npj Parkinson's Disease y respaldado por la Michael J. Fox Foundation, muestra el potencial de IC 100 para ralentizar la progresión de la PD.
Los hallazgos clave demuestran que IC 100 bloquea eficazmente la activación del inflammasoma microglial y reduce la acumulación neurotóxica de alfa-sinucleína, dos factores principales en la progresión de la PD. La investigación, realizada en la University of Miami Miller School of Medicine, revela la primera evidencia que vincula el ensamblaje de ASC speck, la activación del inflammasoma NLRP1 y la agregación de alfa-sinucleína en las neuronas de pacientes con PD.
El mercado global de medicamentos para la PD, valorado en 6.600 millones de dólares en 2024, se proyecta que alcance los 13.300 millones para 2034. A diferencia de los tratamientos actuales que solo abordan los síntomas, IC 100 muestra promesas como terapia modificadora de la enfermedad. ZyVersa planea comenzar estudios de prueba de concepto en animales a finales de este año.
ZyVersa Therapeutics는 파킨슨병(PD) 치료를 위한 염증복합체 ASC 억제제 IC 100의 획기적인 데이터를 발표했습니다. Michael J. Fox 재단의 지원을 받은 npj Parkinson's Disease에 게재된 이 연구는 IC 100이 PD 진행을 늦출 수 있는 가능성을 보여줍니다.
주요 결과는 IC 100이 미세아교세포 염증복합체 활성화를 효과적으로 차단하고, 신경독성 알파-시누클레인 축적을 감소시킨다는 것을 보여줍니다. 이는 PD 진행의 두 가지 주요 요인입니다. 마이애미 대학교 밀러 의과대학에서 수행된 이 연구는 PD 환자 신경세포에서 ASC 스펙 조립, NLRP1 염증복합체 활성화 및 알파-시누클레인 응집을 처음으로 연결하는 증거를 제시합니다.
2024년 66억 달러로 평가된 전 세계 PD 약물 시장은 2034년까지 133억 달러에 이를 것으로 예상됩니다. 현재 증상 완화에만 초점을 맞춘 치료제와 달리, IC 100은 질병 변형 치료제로서의 가능성을 보여줍니다. ZyVersa는 올해 말 동물 대상 개념 증명 연구를 시작할 계획입니다.
ZyVersa Therapeutics annonce des données révolutionnaires concernant leur Inhibiteur de l'inflammasome ASC IC 100 dans le traitement de la Maladie de Parkinson (PD). L'étude, publiée dans npj Parkinson's Disease et soutenue par la Michael J. Fox Foundation, révèle le potentiel de l'IC 100 à ralentir la progression de la maladie.
Les résultats clés montrent que l'IC 100 bloque efficacement l'activation de l'inflammasome microglial et réduit l'accumulation neurotoxique d'alpha-synucléine, deux facteurs majeurs dans la progression de la PD. La recherche, menée à l'Université de Miami Miller School of Medicine, apporte la première preuve reliant l'assemblage du speck ASC, l'activation de l'inflammasome NLRP1 et l'agrégation d'alpha-synucléine dans les neurones des patients atteints de PD.
Le marché mondial des médicaments contre la PD, évalué à 6,6 milliards de dollars en 2024, devrait atteindre 13,3 milliards d'ici 2034. Contrairement aux traitements actuels qui ne font que soulager les symptômes, l'IC 100 montre un potentiel en tant que thérapie modifiant la maladie. ZyVersa prévoit de débuter des études de preuve de concept sur des animaux d'ici la fin de l'année.
ZyVersa Therapeutics verkündet bahnbrechende Daten zu ihrem Inflammasom ASC-Inhibitor IC 100 bei der Behandlung der Parkinson-Krankheit (PD). Die Studie, veröffentlicht in npj Parkinson's Disease und unterstützt von der Michael J. Fox Foundation, zeigt das Potenzial von IC 100, das Fortschreiten der PD zu verlangsamen.
Wesentliche Ergebnisse zeigen, dass IC 100 die Aktivierung des mikroglialen Inflammasoms effektiv blockiert und die neurotoxische Akkumulation von Alpha-Synuclein reduziert – zwei Hauptfaktoren bei der PD-Progression. Die Forschung, durchgeführt an der University of Miami Miller School of Medicine, liefert erstmals Nachweise, die die ASC-Speck-Assemblierung, die Aktivierung des NLRP1-Inflammasoms und die Alpha-Synuclein-Aggregation in den Neuronen von PD-Patienten miteinander verbinden.
Der globale PD-Arzneimittelmarkt, der 2024 auf 6,6 Milliarden US-Dollar geschätzt wird, soll bis 2034 auf 13,3 Milliarden US-Dollar anwachsen. Im Gegensatz zu aktuellen Behandlungen, die nur Symptome lindern, zeigt IC 100 vielversprechende Ansätze als krankheitsmodifizierende Therapie. ZyVersa plant, noch in diesem Jahr Proof-of-Concept-Tierstudien zu starten.
- IC 100 shows promising results in blocking microglial inflammasome activation and reducing alpha-synuclein in Parkinson's disease
- Large market opportunity with PD drug market valued at $6.6B in 2024, projected to reach $13.3B by 2034
- Research supported by prestigious Michael J. Fox Foundation grant
- Study published in peer-reviewed Nature journal strengthens scientific credibility
- Preparing to initiate proof-of-concept animal studies later this year
- Potential application beyond PD to include Lewy body dementia and Alzheimer's Disease
- Still in early research phase - no human clinical trials yet
- Will require significant time and capital to progress through clinical development
- Faces competition in large PD drug market
- No immediate revenue potential from this program
Insights
ZyVersa's IC 100 shows promise for Parkinson's disease by targeting dual disease mechanisms, representing significant potential in a $13.3B future market.
ZyVersa's preclinical research published in npj Parkinson's Disease (a Nature journal) demonstrates their Inflammasome ASC Inhibitor IC 100 addresses two key pathological processes in Parkinson's disease: microglial inflammasome activation and neurotoxic alpha-synuclein accumulation. This dual-targeting mechanism distinguishes IC 100 from NLRP3-specific inhibitors, potentially offering more comprehensive disease modification. The global Parkinson's market represents a substantial opportunity, valued at
This research addresses a critical unmet need, as current PD treatments only manage symptoms rather than modifying disease progression. Though promising, these results are pre-animal studies, placing IC 100 at an early developmental stage. ZyVersa plans to advance to proof-of-concept animal studies later this year - a significant developmental milestone. The Michael J. Fox Foundation's support adds credibility to this approach and research partnership with University of Miami Miller School of Medicine.
Beyond Parkinson's disease, the research suggests potential applications in Lewy body dementia and Alzheimer's Disease, potentially expanding IC 100's therapeutic reach across multiple neurodegenerative conditions with similar underlying pathologies.
ZyVersa's IC 100 demonstrates groundbreaking dual mechanism inhibiting both inflammasome activation and alpha-synuclein accumulation in Parkinson's disease.
The newly published data in Nature's npj Parkinson's Disease reveals a critical pathological connection in Parkinson's disease that has significant therapeutic implications. The study identified ASC and NLRP1 in the core of alpha-synuclein Lewy bodies from PD patients, establishing a direct link between inflammasome activation and protein aggregation pathology - two processes previously viewed separately.
What makes IC 100 particularly promising is its targeting of ASC - the central adaptor protein for multiple inflammasome types - providing broader inflammasome suppression than NLRP3-specific inhibitors. The data shows that ASC specks from PD patient brains triggered inflammasome activation and cell death in human microglia, which was effectively blocked by IC 100.
Most importantly, IC 100 demonstrated ability to alter cellular distribution and decrease levels of phosphorylated alpha-synuclein, indicating improved clearance of the pathogenic proteins that drive neurodegeneration. The observation of granular neuron loss in PD patient tissues confirms the urgent need for interventions specifically targeting the neurodegenerative process.
This approach simultaneously addresses both protein aggregation and neuroinflammation, potentially modifying two central disease processes rather than merely treating symptoms. As lead researcher Dr. Robert Keane notes, this mechanism could have applications beyond Parkinson's, including Lewy body dementia and Alzheimer's Disease - expanding its potential therapeutic impact.
- Study supported by the Michael J. Fox Foundation through a grant awarded to ZyVersa and leading inflammasome experts at University of Miami Miller School of Medicine who conducted the study.
- Parkinson’s Disease (PD) affects over 10 million people globally and is driven by inflammation leading to progressive neurodegeneration resulting in impaired mobility, cognitive decline, and other neurological symptoms.
- Abnormal alpha-synuclein accumulation/aggregation and inflammasome activation are key contributors to PD progression; targeting both may help slow or halt disease advancement.
- Current PD treatments address only symptoms—not the underlying disease; the global PD drug market was valued at
$6.6 billion in 2024 and is projected to reach$13.3 billion by 2034 (Precedence Research).
WESTON, Fla., April 29, 2025 (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 newly published data supporting the potential of its Inflammasome ASC Inhibitor IC 100 to slow the progression of Parkinson’s disease.
Published in npj Parkinson's Disease, a peer-reviewed journal from Nature, the study presents groundbreaking findings from researchers at the University of Miami Miller School of Medicine. The research demonstrates that IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation—both key contributors to PD progression.
“These are the first data to link ASC speck assembly, NLRP1 inflammasome activation, and alpha-synuclein aggregation in neurons of Parkinson’s disease patients,” said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “IC 100, which unlike NLRP3 inhibitors, targets ASC, ASC specks, and multiple types of inflammasomes, blocked microglial NLRP1 inflammasome activation and reduced alpha-synuclein accumulation. These results strengthen our belief in IC 100 as a potential disease-modifying therapy for Parkinson’s, and we’re preparing to initiate proof-of-concept studies in animal models later this year.”
Study Highlights
- ASC and NLRP1 were present in the core of alpha-synuclein in neuronal Lewy bodies of PD patients, suggesting inflammasomes, ASC specks, and other aggregated proteins, including alpha-synuclein, exacerbate neurodegeneration in PD.
- Granular neuron loss was observed in PD patient tissues, highlighting the need for interventions that can mitigate neurodegeneration.
- ASC specks from PD patient brains triggered inflammasome activation and cell death in human microglia. This was blocked by IC 100.
- Preformed alpha-synuclein fibrils from brains of PD patients significantly increased total and phosphorylated alpha-synuclein and ASC specks in microglia, triggering inflammasome activation that was inhibited by IC 100.
- IC 100 altered the cellular distribution and decreased levels of phosphorylated alpha-synuclein, indicating improved clearance of pathogenic alphaαα-synuclein.
“Our findings demonstrate that targeting inflammasomes and ASC specks may be a promising approach not only for PD but also for Lewy body dementia (LBD) and Alzheimer’s Disease,” said Dr. Robert W. Keane, Professor of Physiology and Biophysics, Neurological Surgery, and Microbiology & Immunology at the University of Miami, and lead author of the study. “IC 100’s mechanism, which uniquely inhibits both ASC speck activity and misfolded protein aggregates, makes it a strong candidate for treating neurodegenerative diseases.”
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 with certain 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™ 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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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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