Metabolic Syndrome

TAIPEI, Oct. 29, 2024 /PRNewswire/ -- Foresee Pharmaceuticals Co., Ltd. (TPEx: 6576), ("Foresee") announced today that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer. This NDA submission is supported by a previously successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint. "Following the successful launch of CAMCEVI 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of CAMCEVI NDA to the U.S. FDA. This marks a significant milestone in our efforts to expand treatment options for patients with advanced prostate cancer. We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile," said Dr. Ben Chien, Founder and Chairman of Foresee. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 6-month depot formulation, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan and Israel and launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month depot formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study, is ongoing. Another indication of CAMCEVI 6-month depot formulation, premenopausal breast cancer, the Phase 3 clinical trial in China is ongoing as well. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, for which a Phase 1 study in healthy volunteers has been successfully completed, with development targeted in severe asthma, COPD and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Data unveils new insights into treatment for type 2 diabetes, obesity, cardiovascular, kidney and liver diseases Cardiometabolic diseases, including cardiovascular disease, obesity, type 2 diabetes, and MASH, are increasing in prevalence in the U.S. and are associated with high disease burden and increased medical costs1-4 Multiple presentations planned at Kidney Week 2024, ObesityWeek®, The Liver Meeting®, and American Heart Association (AHA) Scientific Sessions 2024 PLAINSBORO, N.J., Oct. 23, 2024 /PRNewswire/ -- Novo Nordisk today announced that new clinical trial data spanning the company's research and industry-leading cardiometabolic portfolio, will be presented across four medical congresses, building on the company's focus on driving change to defeat serious chronic disease and improve patient care. These upcoming presentations will add to the data about semaglutide's effects on cardiometabolic conditions and build on previously presented findings. "Cardiometabolic diseases represent some of the most significant health challenges facing the world today. Our cardiometabolic research is deepening our understanding of the interconnected nature of chronic conditions such as diabetes, obesity, cardiovascular, kidney, and liver diseases," said Michelle Skinner, PharmD, Vice President, Medical Affairs at Novo Nordisk. "Through research, we aim to further explore treatment options for those most affected, aligning with our commitment to advance scientific frontiers in chronic disease management." A significant number of Americans are affected by cardiometabolic diseases, which have been on the rise during the last several decades.1 T2D and cardiovascular disease (CVD) are highly prevalent,5,6 and CVD is the leading cause of death in the U.S.7 Having either obesity or CKD increases the risk of developing interconnected cardiometabolic disease.8-10 The obesity epidemic also is contributing to the increasing global prevalence of MASH (metabolic dysfunction-associated steatohepatitis), a serious chronic condition caused by the buildup of extra fat in the liver and characterized by liver inflammation and injury, with or without fibrosis.11-14 The totality of Novo Nordisk data to be presented at these upcoming congresses will further highlight Novo Nordisk's commitment to researching serious, chronic diseases. "Patients with cardiometabolic disease face a host of comorbid conditions. Improving care for them by helping reduce their risk of developing serious, potentially life-threatening complications is at the core of Novo Nordisk's research and development program, and this will be reflected in our upcoming data presentations," said Michelle Skinner. "We are excited to share our growing body of data investigating semaglutide and its potential to provide broader benefits to patients living with these common and intractable diseases." Select Novo Nordisk abstracts to be presented, these data for semaglutide are investigational: American Society of Nephrology, Kidney Week 2024, October 23 to 27 [San Diego] ObesityWeek® 2024, November 3 to 6 [San Antonio] The American Association for the Study of Liver Diseases (The Liver Meeting ® ) 2024, November 15 to 19 [San Diego] American Heart Association Scientific Sessions 2024, November 16 to 19 [Chicago] About Cardiometabolic Diseases Cardiometabolic diseases encompass some of the most significant health challenges facing the world today. These common conditions, which often overlap and can coexist in the same patient, include CVD and metabolic diseases, such as T2D, obesity, and MASH.15,16 A significant proportion of the cardiovascular risk associated with these diseases is attributable to shared metabolic risk factors.16 CVD accounts for around 70% of deaths in people living with obesity and is the leading cause of death in people with T2D, CKD and MASH.9,16, 17,18 About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With its U.S. headquarters in New Jersey and commercial, production, and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, X, LinkedIn, and YouTube. _______________ References Reiter-Brennan C, Dzaye O, Davis D, et al. Comprehensive care models for cardiometabolic disease. Curr Cardiol Rep. 2021;23(3):22. Published 2021 Feb 24. doi:10.1007/s11886-021-01450-1. Jardim TV, Mozaffarian D, Abrahams-Gessel S, et al. Cardiometabolic disease costs associated with suboptimal diet in the United States: A cost analysis based on a microsimulation model. PLoS Med. 2019;16(12):e1002981. Published 2019 Dec 17. doi:10.1371/journal.pmed.1002981. MedlinePlus: Non-alcoholic fatty liver disease. Available at: . Last Accessed October 2024. American Liver Foundation. NASH definition & prevalence. Last updated July 2, 2021. Last accessed: October 2024. Available at: . Centers for Disease Control and Prevention. Type 2 Diabetes. Last accessed September 2024. Available at: . Roth GA, Mensah GA, Johnson CO, et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019. J Am Coll Cardiol. 2020;76(25):2982-3021. doi:10.1016/j.jacc.2020.11.010. Centers for Disease Control and Prevention. Leading Causes of Death. Last accessed: September 2024. Available at: . Valenzuela PL, Carrera-Bastos P, Castillo-García A, et al. Obesity and the risk of cardiometabolic diseases. Nat Rev Cardiol. 2023;20(7):475-494. doi:10.1038/s41569-023-00847-5. Jankowski J, Floege J, Fliser D, Böhm M, Marx N: Cardiovascular disease in chronic kidney disease: pathophysiological insights and therapeutic options. Circulation. 2021, 143:1157-72. 10.1161/CIRCULATIONAHA.120.050686. Sanyal AJ, Husain M, Diab C, et al. Cardiovascular disease in patients with metabolic dysfunction-associated steatohepatitis compared with metabolic dysfunction-associated steatotic liver disease and other liver diseases: A systematic review. Am Heart J Plus. 2024;41:100386. Published 2024 Mar 24. doi:10.1016/j.ahjo.2024.100386. Global Liver Institute. The language of NASH. Accessed August 29, 2023. . Chalasani N, Younossi Z, Lavine JE, et al. The diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018;67(1):328-357. Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018;67(1):123-133. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64(1):73-84. Marassi M, Fadini GP. The cardio-renal-metabolic connection: a review of the evidence. Cardiovasc Diabetol. 2023 Jul 31;22(1):195. doi: 10.1186/s12933-023-01937-x. PMID: 37525273; PMCID: PMC10391899. Shroff H, VanWagner LB. Cardiovascular Disease in Nonalcoholic Steatohepatitis: Screening and Management. Curr Hepatol Rep. 2020;19(3):315-326. doi:10.1007/s11901-020-00530-0. Khafagy R, Dash S. Obesity and Cardiovascular Disease: The Emerging Role of Inflammation. Front Cardiovasc Med. 2021;8:768119. Published 2021 Oct 25. doi:10.3389/fcvm.2021.768119. Ma, CX., Ma, XN., Guan, CH. et al. Cardiovascular disease in type 2 diabetes mellitus: progress toward personalized management. Cardiovasc Diabetol 21, 74 (2022). . © 2024 Novo Nordisk All rights reserved. US24OB00483 October 2024 SOURCE Novo Nordisk Inc. 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ECC5004/AZD5004 is an investigational oral small molecule GLP-1 receptor agonist licensed to AstraZeneca in November 2023BOSTON, Mass. and SHANGHAI, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions, announced that it will receive a $60 million payment from AstraZeneca, which is being triggered by successfully achieving milestones related to the development of ECC5004/AZD5004 including the first patient dosed in the Phase 2b program. VISTA (NCT06579092) and SOLSTICE (NCT06579105) are two global Phase 2b multicenter trials assessing the efficacy and safety of ECC5004/AZD5004, administered orally, once daily, to participants who are obese or overweight with at least one weight-related comorbidity and type 2 diabetes, respectively. AstraZeneca licensed the global rights to ECC5004/AZD5004 from Eccogene in November 2023, for which the Company received an upfront payment of $185 million and can receive up to $1.825 billion in future milestones, as well as royalty payments. Eccogene retains co-development and co-commercialization rights to ECC5004/AZD5004 in China. “Obesity and its associated comorbidities affect over one billion people worldwide and continue to grow in prevalence. We are pleased to see ECC5004/AZD5004 – our internally discovered oral small molecule GLP-1 receptor agonist – advancing into Phase 2b clinical trials for obesity and type 2 diabetes. This is an important milestone for Eccogene, as it provides strong validation for our translational research platform and underscores the efficiency and effectiveness of our close collaboration with AstraZeneca,” said Jingye Zhou, Chief Executive Officer of Eccogene. Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, commented: “Rapidly progressing AZD5004 is a priority, as novel solutions are needed for patients to address interrelated cardiometabolic disease and the serious risks associated with type 2 diabetes, obesity or overweight with comorbidities. The start of our two Phase 2b trials marks a significant milestone in our efforts to provide an alternative to current injectable therapies that can be offered as a monotherapy as well as in combination for addressing interrelated diseases.” Leveraging its translational research platform and deep understanding of metabolic disease pathways – in addition to ECC5004/AZD5004 – Eccogene discovered and is advancing a pipeline of next-generation oral therapeutics that can be used alone or in combination with GLP-1 receptor agonists. This includes the Company’s clinical-stage THR-β agonist and SSAO inhibitor – both of which are differentiated compounds, and when used in combination, can potentially help augment the efficacy of GLP-1 to address comorbidities of obesity. Eccogene is also advancing several innovative preclinical programs, such as a small molecule GIP receptor modulator. About EccogeneEccogene is a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions. Since its founding, Eccogene has been dedicated to discovering safer and more effective oral therapies that can be used alone or synergistically with a GLP-1 receptor agonist to treat conditions beyond obesity. The Company’s diverse pipeline of small molecule candidates leverages its world-class expertise in translational research, small molecule discovery, and a deep understanding of diabetes, weight loss, and cardiometabolic disease pathways. Eccogene’s oral small molecule GLP-1 receptor agonist, ECC5004/AZD5004, is a potentially best-in-class asset, which was licensed to AstraZeneca. Eccogene also has clinical programs underway that target THR-β and SSAO, as well as preclinical programs targeting proven pathways, such as GIP. For more information, please visit www.eccogene.com or follow the Company on LinkedIn. Media Contact Amy BonannoLyra Strategic Advisoryabonanno@lyraadvisory.com