Latest news with #fibrosis
Medscape
10 hours ago
- Health
- Medscape
Wegovy Approved for MASH With Fibrosis, No Cirrhosis
On Friday, the FDA granted accelerated approval to Novo Nordisk's Wegovy for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis but without cirrhosis. The once-weekly 2.4 mg semaglutide subcutaneous injection is given in conjunction with a reduced calorie diet and increased physical activity. Among people living with overweight or obesity globally, 1 in 3 also have MASH. The accelerated approval was based on part-one results from the ongoing two-part, phase-3 ESSENCE trial, in which Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis, compared with placebo at week 72. Those results were published online in April in The New England Journal of Medicine . For the trial, 800 participants were randomly assigned to either Wegovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 34. Most patients were white individuals (67.5%) and women (57.1%), and 55.9% of the patients had type 2 diabetes; 250 patients (31.3%) had stage II fibrosis and 550 (68.8%) had stage III fibrosis. Participants were on stable doses of lipid-lowering, glucose-management, and weight-loss medications. At week 72, the first primary endpoint showed 63% of the 534 people treated with Wegovy achieved resolution of steatohepatitis and no worsening of liver fibrosis compared with 34% of 266 individuals treated with placebo — a statistically significant difference. The second primary endpoint showed 37% of people treated with Wegovy achieved improvement in liver fibrosis and no worsening of steatohepatitis compared with 22% of those treated with placebo, also a significant difference. A confirmatory secondary endpoint at week 72 showed 33% of patients treated with Wegovy achieved both resolution of steatohepatitis and improvement in liver fibrosis compared with 16% of those treated with placebo — a statistically significant difference in response rate of 17%. In addition, 83.5% of the patients in the semaglutide group maintained the target dose of 2.4 mg until week 72. Wegovy is also indicated, along with diet and physical activity, to reduce the risk for major cardiovascular events in adults with known heart disease and with either obesity or overweight. It is also indicated for adults and children aged 12 years or older with obesity, and some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off. What's Next for Wegovy? In February 2025, Novo Nordisk filed for regulatory approval in the EU, followed by regulatory submission in Japan in May 2025. Also in May, the FDA accepted a filing application for oral semaglutide 25 mg. Furthermore, 'There's an expected readout of part 2 of ESSENCE in 2029, which aims to demonstrate treatment with Wegovy lowers the risk of liver-related clinical events, compared to placebo, in patients with MASH and F2 or F3 fibrosis at week 240,' a Novo Nordisk spokesperson told Medscape Medical News . Although the company has the technology to produce semaglutide as a pill or tablet, she said, 'the US launch of oral semaglutide for obesity will be contingent on portfolio prioritization and manufacturing capacity.' The company has not yet submitted the 50 mg oral semaglutide to regulatory authorities. 'The oral form requires more active pharmaceutical ingredient (API),' she noted. 'Given that we have a fixed amount of API, the injectable form enables us to treat more patients. We are currently expanding our oral and injectable production capacities globally with the aim of serving as many patients as possible. It requires time to build, install, validate, and ramp-up these production processes.'
Medscape
4 days ago
- Health
- Medscape
Novel Lipogenesis Inhibitor Combo Effective Against MASH
TOPLINE: The combination of ervogastat plus clesacostat was more effective at resolving metabolic dysfunction-associated steatohepatitis (MASH) without worsening fibrosis in patients with biopsy-confirmed MASH and stage II or III fibrosis than placebo and ervogastat alone; however, the combination was associated with a potentially unfavorable lipid profile that may make it less suitable for patients at increased risk for cardiovascular events. METHODOLOGY: Reducing liver fat can help manage MASH; two novel inhibitors of de novo lipogenesis — ervogastat, a diacylglycerol O-acyltransferase 2 (DGAT2) inhibitor, and clesacostat, an acetyl-coenzyme A carboxylase (ACC) inhibitor — have demonstrated effects in lowering liver fat in early clinical trials. Researchers conducted a phase 2 clinical trial from June 2020 to February 2024 to assess the efficacy and safety of ervogastat alone and in combination with clesacostat in adults with biopsy-confirmed MASH and stage II or III fibrosis. Overall, 255 patients were randomly assigned to receive ervogastat (25 mg, 75 mg, 150 mg, or 300 mg), ervogastat plus clesacostat (150 mg plus 5 mg or 300 mg plus 10 mg), or placebo twice daily for 48 weeks. The primary endpoint was the proportion of patients achieving MASH resolution without fibrosis worsening, at least a one-stage fibrosis improvement without MASH worsening, or both at week 48. TAKEAWAY: Both dose levels of ervogastat plus clesacostat met the composite primary endpoint. Compared with 38% of patients receiving placebo, 66% of patients receiving 150 mg ervogastat plus 5 mg clesacostat (difference from placebo, 0.27) and 63% receiving 300 mg ervogastat plus 10 mg clesacostat (difference from placebo, 0.25) achieved the primary endpoint. None of the doses of ervogastat alone met the composite primary endpoint. Compared with the placebo group, all ervogastat alone and ervogastat plus clesacostat groups achieved greater improvements in MASH resolution without fibrosis worsening (the MASH component of the primary endpoint); however, no treatment group achieved at least a one-stage improvement in fibrosis without MASH worsening compared with the placebo group (the fibrosis component of the primary endpoint). Most adverse events were mild or moderate in severity, with the most common adverse events being inadequate control of diabetes and diarrhea. Ervogastat plus clesacostat was associated with increased levels of serum triglycerides, apolipoprotein C-3, and apolipoprotein E. IN PRACTICE: 'The results from this study expand on the relevance of DGAT2 inhibitors and the DGAT2 inhibitor plus ACC inhibitor combination in potentially treating MASH with liver fibrosis,' the researchers wrote. 'Significant differences relative to placebo were noted only in the combination therapy groups and mainly driven by resolution of MASH,' Manuel Castro Cabezas of the Erasmus Medical Center, Rotterdam, the Netherlands, and Vivian de Jong of UMC Utrecht, Utrecht, the Netherlands, wrote in an accompanying editorial. 'Cardiovascular health could be an issue with ervogastat and clesacostat due to the negative effects on serum triglycerides and HDL [high-density lipoprotein] levels seen in this trial,' they added. SOURCE: This study, led by Vincent Wai-Sun Wong, MD, The Chinese University of Hong Kong in Hong Kong, China, was published online in The Lancet Gastroenterology & Hepatology. LIMITATIONS: The study was completed with 73% of the randomly assigned patients, with recruitment facing challenges during the COVID-19 pandemic. The reduced sample size likely made the placebo response on histology more sensitive to small shifts in the number of patients classified as responders. DISCLOSURES: This study was funded by Pfizer, which manufactures ervogastat and clesacostat. Three authors disclosed being full-time employment at Pfizer and/or owning stocks in the company. Other authors declared receiving grants and/or fees and having other ties with many pharmaceutical companies, including Pfizer. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Associated Press
05-06-2025
- Business
- Associated Press
Mediar Therapeutics Doses First Patient in Phase 2 WISPer Trial of MTX-463 for Idiopathic Pulmonary Fibrosis
First-in-class agent targets WISP1 in patients with IPF Primary endpoint in WISPer trial is change in Forced Vital Capacity (FVC) at 24 Weeks BOSTON, June 5, 2025 /PRNewswire/ -- Mediar Therapeutics, Inc., a clinical-stage biotechnology company advancing first-in-class therapies designed to halt fibrosis, today announced the first patient has been dosed in its Phase 2 WISPer clinical trial evaluating MTX-463, an investigational therapy for idiopathic pulmonary fibrosis (IPF). The study's primary endpoint is the change from baseline in forced vital capacity (FVC)—an important measure of lung function—at 24 weeks. The study aims to advance the development of a potential novel treatment for patients living with IPF, and targets the myofibroblast, the key pathogenic cell in fibrosis. Mediar recently entered into a global licensing agreement with Lilly to advance MTX-463 through the Phase 2 WISPer trial. IPF is a rare and progressive lung disease characterized by scarring and thickening of lung tissue, which leads to increasing shortness of breath and a persistent dry cough. Despite available treatments, there remains a high unmet medical need, with an average life expectancy of three to five years post-diagnosis. The WISPer trial is a randomized, double-blind, placebo-controlled 24-week Phase 2 study designed to evaluate the efficacy, safety, and tolerability of MTX-463 in patients living with IPF. 'Dosing the first patient in the WISPer trial represents an important step forward in the pursuit of new options to address the urgent needs of individuals living with IPF,' said Toby Maher, MD, PhD, Director of Interstitial Lung Disease, University of Southern California, and lead investigator in the Phase 2 clinical study. 'IPF is a devastating disease with limited treatment options. We are eager to evaluate the potential of MTX-463 to slow or halt disease progression and look forward to the insights this study will provide for patients and their physicians.' 'Today marks an important milestone in our ongoing commitment to pioneering novel therapies to impact people living with fibrotic diseases. We extend our gratitude to Dr. Ryan Klein and the dedicated team at NewportNativeMD whose expertise and collaboration have been instrumental in reaching this important step,' said Jeff Bornstein, MD, Chief Medical Officer, Mediar. 'The first patient dosed with this first-in-class anti-fibrotic marks the beginning of a new chapter in our research, and we look forward to working with our clinical sites as we continue to enroll the Phase 2 program.' Mediar is also independently advancing its two wholly owned programs to treat other fibrotic disorders. MTX-474, a first-in-class human IgG1 antibody designed to neutralize EphrinB2 signaling, recently completed its Phase 1 clinical study. Mediar anticipates initiating a Phase 2 trial for MTX-474 in systemic sclerosis in the second half of 2025. Mediar's third novel fibrosis program, targeting SMOC2 for renal fibrosis, is also advancing with a plan to nominate a clinical candidate in the first half of 2025. About MTX-463 MTX-463 is a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP1). WISP1 is a secreted matricellular protein shown to have a relevant role in fibrosis progression, is measurable in human blood, and correlates with disease severity. Data indicates that MTX-463 neutralizes WISP1-mediated fibrotic signaling and significantly reduced fibrosis in vitro and in various preclinical models. A Phase 1 study was recently completed and a Phase 2 study in patients with IPF is now open (NCT06967805). More information can be found at: About Mediar Therapeutics Mediar Therapeutics is pioneering a new approach to fibrosis treatment that aims to halt the disease at a different source – the myofibroblast, the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure. Mediar was founded based on a deep understanding of the complex science underlying fibrosis progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar's goal is to bring forward novel anti-fibrotic therapies that potentially have a precision medicine approach. For more information, contact [email protected] or follow us on LinkedIn. Media Contact [email protected] View original content to download multimedia: SOURCE Mediar Therapeutics
Yahoo
31-05-2025
- Business
- Yahoo
Gyre Therapeutics, Inc. (GYRE) Raises $23M in Public Stock Offering to Fund Liver Fibrosis Trials
Gyre Therapeutics, Inc. (NASDAQ:GYRE), a biopharmaceutical company developing innovative fibrosis-focused therapies, has successfully closed a public offering, raising approximately $23 million in gross proceeds. The offering included 2,555,555 shares of common stock at $9.00 per share, with Jefferies serving as lead book-running manager and H.C. Wainwright & Co. as co-manager. A research scientist in an idiopathic pulmonary fibrosis laboratory, carrying out clinical trials. The capital infusion, which follows the full exercise of underwriters' options, will support Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s ongoing Phase 2 clinical trial of F351, a promising treatment targeting liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the United States. The funds will also bolster research and development, manufacturing scale-up, and general corporate operations. The shares were offered under a shelf registration statement previously approved by the SEC. Gyre Therapeutics, Inc. (NASDAQ:GYRE)'s latest fundraising effort underscores its commitment to advancing therapies for chronic diseases marked by fibrosis, aiming to address significant unmet medical needs. While we acknowledge the potential of GYRE to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than GYRE and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Yahoo
16-05-2025
- Health
- Yahoo
Nordic Bioscience launches novel Endotrophin assay
HERLEV, Denmark, May 16, 2025 /CNW/ -- Nordic Bioscience introduces nordicEndotrophin™, a fully automated high-precision assay that selectively quantifies the intact 77-amino-acid Endotrophin signaling hormone—qualified in the CAP/CLIA certified Nordic Bioscience laboratory. When integrated with the company's existing product line, the biomarker assay demonstrated prognostic utility in fibrosis and cancer studies1. NordicEndotrophin™ joins nordicPRO-C6™ and nordicPRO-C3™ (in-house versions of the FDA-supported PRO-C6 and CE approved PRO-C3 assays) to deliver a one-stop solution for assessing the fibro-inflammatory axis in chronic diseases, including cardiovascular, metabolic, renal and more. Following PRO-C3's recent deployment on Roche IVD platforms, the new Endotrophin assay strengthens risk stratification and pharmacodynamic monitoring. Endotrophin was first identified in 2012 as a collagen-derived hormone released from type VI collagen. Type VI collagen is a contributor to fibroblast activation and driver of fibrosis across organs—inflammatory processes that underlie roughly 40 percent of deaths in Western countries2. Obesity exacerbates this by activating fibroblasts in the liver, kidney and heart. Across a range of chronic diseases, patients with a two-fold increase of circulating Endotrophin levels increased risk of mortality by 100%1,2. Quantifying Endotrophin enables researchers to connect wound healing and fibrotic progression to patient outcomes, supporting precision-medicine approaches that pharmacodynamically modulate this dangerous hormone. Whereas PRO-C6, Nordic Bioscience's first hand-held ELISA assay measuring the formation of the total pool of type VI collagen (a3 chain encompassing 12 Von Willebrand binding domains), a collagen responsible for binding of platelets that cause fibroblast activation and would healing, nordicEndotrophin™ specifically measures the intact 77-amino-acid hormone. This specificity means additional risk stratification and prognostic value that complement PRO-C6's fibrosis-driven pharmacodynamic insights1. "Endotrophin is a significant prognostic biomarker to emerge," said CEO Dr. Morten Karsdal. "Evidenced in a study of HFpEF patients, Endotrophin and PRO-C6 outperformed NT-proBNP in HFpEF for mortality and hospitalization risk3. Together with PRO-C3, quantifying this fibro-inflammatory hormone will refine patient stratification and treatment monitoring across obesity, fibrotic diseases, and autoimmune endotypes." Offered in Nordic Bioscience's CAP/CLIA-certified laboratory in Herlev, Denmark, the nordicEndotrophin™ high-precision sandwich assay is available on fully automated, high-accuracy, high-throughput platforms. To accelerate drug fibro-inflammatory profiling, clients considering nordicEndotrophin™ are invited to co-measure nordicPRO-C3™ and nordicPRO-C6™. Together, these assays facilitate precise risk stratification, dose selection, patient enrichment, proof-of-mechanism and treatment monitoring in anti-fibrotic and oncology trials2. About Nordic Bioscience Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. We are engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting. For more information about Nordic Bioscience, visit us at References: [1] [2] [3] For product related inquires please use Logo: View original content to download multimedia: SOURCE Nordic Bioscience View original content to download multimedia: Sign in to access your portfolio
