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
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
'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 $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.
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Importantly, this is not a promotional announcement but a sincere effort to clarify its presence in the evolving space of non-clinical tinnitus support. EchoFree is not being positioned as a cure or treatment but rather as part of a broader, nature-driven conversation about supporting neural pathways, promoting clarity of perception, and reducing the mental strain that often accompanies chronic auditory disruptions. As interest grows in formulations that combine ingredients like GABA, Gotu Kola, and Astragalus with cognitive-supporting amino acids, EchoFree has chosen to contribute to the conversation by outlining how its formulation aligns with these emerging expectations. This press release offers a structured overview of the formulation's ingredient transparency, relevant market trends, and evolving consumer perspectives. We believe in empowering our consumers with knowledge. Hence, we have carefully crafted this release to provide you with valuable insights while strictly adhering to industry and compliance standards and avoiding promotional or medical claims. Company/Product Announcement or Update EchoFree latest 2025 research's statement clarifies the composition and intended design of its plant-based auditory support formulation. Developed in response to increased consumer curiosity around natural strategies for sensory balance, EchoFree is a testament to our commitment to your wellness. It includes a set of widely recognized ingredients chosen for their alignment with cognitive calm and neural clarity. Rather than offering treatment or symptomatic relief, the formulation is designed as a non-clinical wellness companion, containing elements such as calming amino acids, adaptogenic herbs, and antioxidant-rich compounds. These ingredients were selected not for prescriptive outcomes but for their compatibility with wellness routines that emphasize daily support, ingredient minimalism, and ease of use. The company maintains that EchoFree's formula is intended to complement, not replace, broader lifestyle practices aimed at supporting the auditory system and managing the stress that may influence sensory perception. This positioning aligns with the growing market preference for formulas that are transparent in origin, modest in claim, and constructed to support wellness from the inside out. Trend Analysis / Consumer Interest Overview The search for natural tinnitus support has become a growing consumer priority, especially in 2025, as discussions surrounding hearing health, auditory stress, and lifestyle-based interventions continue to increase. Online behavior shows a steady rise in searches related to non-clinical auditory wellness — including terms like 'ringing in ears natural remedy,' 'calm auditory system,' 'tinnitus relief drops,' and 'plant-based support for hearing.' Industry observers have noted this rise across multiple platforms, including wellness blogs, integrative medicine forums, and peer-curated product discovery threads. These conversations reflect a shift from traditional intervention models to a more preventive, maintenance-oriented approach. Many individuals are now seeking ingredient transparency and simplified formulations that fit into daily wellness routines — without requiring synthetic chemicals, complex usage schedules, or prescription-based interventions. In this environment, products like EchoFree are not emerging as miracle solutions but rather as part of a broader narrative—one that centers on ingredient integrity, cognitive balance, and holistic nervous system support. Public commentary has shown growing curiosity about how lifestyle stressors — including prolonged screen time, overstimulation, and poor sleep hygiene — may contribute to auditory discomfort. It's important to note that these are non-diagnostic observations, prompting consumers to research options that prioritize nervous system regulation and mental clarity. As part of its 2025 update, EchoFree has acknowledged these emerging interests and sought to address them through a transparency-first lens. While the company does not position its formula as a treatment or cure, it recognizes the value of aligning its product information with the expectations of modern wellness consumers. This includes clearly listing functional ingredients, sourcing details, and the intended lifestyle alignment of the formula — particularly in how it may be integrated as part of a broader wellness regimen. 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Some commentators have viewed the absence of bold marketing claims as a sign of responsible positioning, particularly in a space where exaggerated testimonials and unverified endorsements have become commonplace. No guarantees or outcomes are being implied or promised in association with the product. Instead, EchoFree has reaffirmed that the formulation is best understood within the context of informational transparency and ingredient integrity. Its intended audience includes wellness seekers who are not looking for overnight results but rather a relatively long-term alignment with calming, supportive daily regimens. By remaining neutral in tone and focused on education over hype, EchoFree's public perception aligns with the 2025 trend toward functional wellness products that prioritize internal balance and self-guided exploration. In doing so, it reflects an evolving set of consumer values — ones centered on autonomy, mindfulness, and ingredient clarity. 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