Latest news with #IC100
Yahoo
07-05-2025
- Health
- Yahoo
ZyVersa Unveils Groundbreaking Potential of Inflammasome Inhibitors in Combination with GLP-1 Agonists to Address Unmet Medical Needs of People Living with Obesity; Provides R&D Update
Available inflammasome inhibitor preclinical data in diet-induced obesity animal models provide proof-of-concept for inflammasome inhibitors as promising therapeutic options for obesity and its associated cardiometabolic conditions when used as add-on therapy to GLP-1 agonists. Importantly, GLP-1 agonists do not fully address the inflammasome-driven chronic, systemic inflammation affecting the hypothalamus that drives obesity, as well as adipose tissue, liver, pancreas, muscle, and gut that dysregulate metabolism in these tissues leading to comorbid conditions Around 65% of non-diabetic patients discontinue GLP-1 agonist treatment within a year and 85% within 2 years - a key driver is GI side effects, which affect 40% - 70% of patients Muscle loss is common, with patients losing 20% to 40% of muscle along with their fat loss Obesity has reached pandemic proportions, affecting over 40% of Americans, with a projected increase to 51% of the global population within 12 years if current trends continue. This condition is intricately linked to various chronic diseases, including type 2 diabetes, cardiovascular disease, non-alcoholic fatty liver disease, and certain cancers. The economic impact is staggering, with global costs projected to exceed $4.32 trillion annually by 2035 without improved prevention and treatment options. WESTON, Fla., May 07, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA), a clinical-stage biopharmaceutical company specializing in first-in-class therapies for inflammatory and renal diseases, announces significant developments for Inflammasome ASC Inhibitor IC 100. CEO Stephen C. Glover issued a shareholder letter detailing the company's strategy to position IC 100 as a complementary therapy to GLP-1 agonists to treat obesity-associated cardiometabolic complications. Story Continues There is also potential to reduce the dose of GLP-1 agonists with add-on inflammasome inhibitor treatment to help alleviate GI side effects and thus improve duration of anti-obesity therapy. IC 100: Targeting the Source of Inflammation While most inflammasome inhibitors in development are small molecules targeting NLRP3, IC 100 was designed to uniquely inhibit ASC and ASC specks to attenuate not only initiation of the inflammatory cascade, but more importantly to attenuate the perpetuation and spread of inflammation contributing to development of obesity-associated cardiometabolic comorbidities. By targeting ASC, IC 100 also inhibits activation of multiple types of inflammasomes that are associated with obesity and its associated complications: Obesity: AIM2, NLRP3 Insulin Resistance: AIM2, NLRP1, NLRP3, NLRC4, NLRP6 Diabetic Nephropathy: AIM2, NLRP3 Preclinical data available to date demonstrate IC 100's potential to address cardiometabolic comorbidities: In an ApoE knockout model of atherosclerosis, IC 100 demonstrated a reduction in inflammation and plaque in the aorta In an obese animal model of diabetic kidney disease, IC 100 lowered fasting blood glucose levels, suggestive of reduced insulin sensitivity In multiple studies in numerous disease states, including CNS and peripheral diseases, IC 100 blocked proinflammatory cytokines, IL-1β, IL-18, and IL-6 that drive inflammation Strategic Development Plans and Milestones ZyVersa has outlined a comprehensive development plan for IC 100, with key milestones anticipated over the next 12 months: H1-2025: Initiate preclinical study in diet-induced obesity (DIO) mouse model to evaluate IC 100's efficacy as monotherapy and in combination with semaglutide H2-2025: Submit an Investigational New Drug (IND) application for IC 100 H1-2026: Commence Phase 1 clinical trials in overweight subjects (BMI 27–30) with cardiometabolic risk factors to assess safety and biomarkers of cardiometabolic risk These studies aim to demonstrate that IC 100, when added to GLP-1 agonist therapy, can reduce the underlying inflammation of obesity, with potential to reduce progression to associated cardiometabolic comorbidities, while augmenting weight loss. Collaborations and Scientific Advisory Support To support the development of IC 100, ZyVersa has formed a Scientific Advisory Board comprising leading experts in obesity, metabolic diseases, and inflammasome biology. This board will provide strategic guidance as the company advances IC 100 through clinical development. Additionally, ZyVersa has engaged in preclinical collaborations to explore the potential of IC 100 in treating Parkinson's disease, further expanding the therapeutic applications of this novel inflammasome ASC inhibitor. Conclusion With the development of IC 100, ZyVersa Therapeutics is poised to make significant strides in the comprehensive treatment of obesity and its associated cardiometabolic complications. By targeting the root cause of chronic inflammation, IC 100 has the potential to complement existing therapies, offering a more holistic approach to managing obesity and improving patient outcomes. The company's strategic development plan, coupled with expert collaborations, underscores its commitment to addressing the unmet medical needs in this critical area of healthcare. We look forward to updating you on our value-building near-term results from our IC 100 development program. Thank you for your continued support. Sincerely, Stephen C. Glover Co-Founder, Chairman, Chief Executive Officer, and President ZyVersa Therapeutics 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 renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit 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, IR, and Media Contact Karen Cashmere Chief Commercial Officer kcashmere@ 786-251-9641
Associated Press
29-04-2025
- Health
- Associated Press
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 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
Associated Press
27-02-2025
- Business
- Associated Press
ER2: Transforming Communities Through Technology and Service
In the rapidly evolving world of technology and sustainability, Electronic Responsible Recyclers (ER2) has earned the prestigious FedEx Champion of Global Entrepreneurship award. Sponsored by FedEx, this award celebrates businesses that exemplify innovation, sustainability, and social impact on a global scale. The recognition is annually conferred to one company on the Inner City 100 list, which honors the 100 fastest-growing companies in under-resourced communities across the United States. The 2024 IC100 winners were unveiled at ICIC's 30th Anniversary Celebration. Speaking about the award, Jenny Robertson, Senior Vice President of Global Brand and Communications at FedEx, stated, 'FedEx equips entrepreneurs from all backgrounds with the training, connections, and access to capital they need to more effectively compete in the global marketplace, build a customer base, generate new jobs, and create a better living for themselves and their communities.' Founded by Chris Ko, ER2 specializes in helping large companies manage their IT hardware assets throughout their lifecycle — from acquisition to disposal. What sets ER2 apart, however, is its commitment to making a difference. 'We recycle IT hardware and donate it to underprivileged families, students, and veterans all across the world,' Ko explains. By extending the life of technology, ER2 not only supports sustainability but also helps underserved communities gain access to essential tools. A Global Footprint with Local Impact ER2 works with some of the largest Fortune 100 companies, providing seamless service across the globe, including regions like the UAE, India, and South America. 'Our objective is to help service [international clients] just like we do stateside,' Ko says. Internationally, ER2's contributions include donating 2,000 keyboards to a school in Africa, giving students their first hands-on typing experience. As Ko puts it, 'These are the little things we can do to empower others to transform their lives by investing in themselves and embracing technology that once felt out of reach.' But ER2's impact is just as profound locally. The company donates about 1,000 laptops annually to programs like Nashville's Anywhere Access for All, helping underserved populations and elderly residents access technology and training. Robertson further emphasized the importance of these efforts, saying, 'Small businesses are critical to the success of FedEx — not only as customers, but as suppliers and vendors as well. Our collaboration with ICIC furthers our goals to empower entrepreneurs by supporting programming for small business owners from under-resourced communities.' A Culture of Service and Humility ER2's mission is deeply rooted in its core values of servanthood, humility, excellence, and continuous improvement. From high-fiving team members at the start of the day to fostering an environment of camaraderie, the company prioritizes people at every level. 'We started our organization trying to create a place where people feel actually real, valued, cared for, embraced, and loved exactly as they are,' Ko shares. This positive culture extends to ER2's clients, team members, and global community. Rocky Jackson, a key team member, notes, 'The people are the most unique asset that we have is absolutely a place that most of our team members love coming into in the mornings.' Unity in Action As an alumnus of ICIC programs, Ko recognizes the power of collaboration and shared knowledge. 'In this type of network, we're able to bounce ideas off of each other, overcome obstacles, and provide insights to promote people doing similar things in different ways,' he explains. This spirit of teamwork aligns closely with the broader goals of FedEx. As Robertson puts it, 'FedEx is committed to making a meaningful difference in communities by promoting positive change.' As a FedEx Champion of Global Entrepreneurship, ER2 exemplifies how businesses can drive innovation and create lasting impact. Ko emphasizes the importance of defining a clear vision, mission, and values, which serve as guiding principles for ER2. 'Everyone in our company knows them. It's something we absolutely constantly stay focused on because we don't ever want to lose sight of why we're doing what we're doing and the impact that we can have,' he says. Looking Ahead ER2's recognition as a FedEx Champion of Global Entrepreneurship underscores its ability to merge sustainability, innovation, and community impact into a successful business model. From recycling IT assets to bridging the digital divide, ER2's work demonstrates the power of socially conscious entrepreneurship. By sharing stories like ER2's, ICIC and FedEx continue their mission of empowering small businesses and entrepreneurs to build a better future. ER2's journey serves as a shining example of how businesses can create meaningful change, one laptop, one keyboard, and one connection at a time. About the IC100 Awards Since 1999, ICIC has identified and honored the 100 fastest-growing businesses located in under-resourced communities through the prestigious Inner City 100 (IC100) awards. Throughout this period, ICIC has had the privilege of learning about and highlighting more than 1,000 remarkable business leaders and companies from across the United States. These firms have proven to be catalysts for job growth and promoters of a thriving, inclusive economy, even amidst challenging circumstances. Furthermore, they have actively contributed to the enhancement of their communities by generously donating their time and resources to local organizations and charitable causes.
