A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (IIM)

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")

开始日期2023-09-05

申办/合作机构

Immunoforge Co. Ltd.初创企业

100 项与 Froniglutide 相关的临床结果

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100 项与 Froniglutide 相关的转化医学

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100 项与 Froniglutide 相关的专利（医药）

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项与 Froniglutide 相关的文献（医药）

2022-08-01·Journal of Cachexia, Sarcopenia and Muscle

Amelioration of inflammatory myopathies by glucagon‐like peptide‐1 receptor agonist via suppressing muscle fibre necroptosis

Article

作者: Mizoguchi, Fumitaka ; Yasuda, Shinsuke ; Kamiya, Mari

AbstractBackgroundAs glucocorticoids induce muscle atrophy during the treatment course of polymyositis (PM), novel therapeutic strategy is awaited that suppresses muscle inflammation but retains muscle strength. We recently found that injured muscle fibres in PM undergo FASLG‐mediated necroptosis, a form of regulated cell death accompanied by release of pro‐inflammatory mediators, contributes to accelerate muscle inflammation and muscle weakness. Glucagon‐like peptide‐1 receptor (GLP‐1R) agonists have pleiotropic actions including anti‐inflammatory effects, prevention of muscle atrophy, and inhibition of cell death, in addition to anti‐diabetic effect. We aimed in this study to examine the role of GLP‐1R in PM and the effect of a GLP‐1R agonist on in vivo and in vitro models of PM.MethodsMuscle specimens of PM patients and a murine model of PM, C protein‐induced myositis (CIM), were examined for the expression of GLP‐1R. The effect of PF1801, a GLP‐1R agonist, on CIM was evaluated in monotherapy or in combination with prednisolone (PSL). As an in vitro model of PM, C2C12‐derived myotubes were treated with FASLG to induce necroptosis. The effect of PF1801 on this model was analysed.ResultsGLP‐1R was expressed on the inflamed muscle fibres of PM and CIM. The treatment of CIM with PF1801 in monotherapy (PF) or in combination with PSL (PF + PSL) suppressed CIM‐induced muscle weakness (grip strength, mean ± SD (g); PF 227 ± 6.0 (P < 0.01), PF + PSL 224 ± 8.5 (P < 0.01), Vehicle 162 ± 6.0) and decrease in cross‐sectional area of muscle fibres (mean ± SD (μm2); PF 1896 ± 144 (P < 0.05), PF + PSL 2018 ± 445 (P < 0.01), Vehicle 1349 ± 199) as well as the severity of histological inflammation scores (median, interquartile range; PF 0.0, 0.0–0.5 (P < 0.05), PF + PSL 0.0, 0.0–0.0 (P < 0.01), Vehicle 1.9, 1.3–3.3). PF1801 decreased the levels of inflammatory mediators such as TNFα, IL‐6, and HMGB1 in the serum of CIM. PF1801 inhibited necroptosis of the myotubes in an AMP‐activated protein kinase (AMPK)‐dependent manner. PF1801 activated AMPK and decreased the expression of PGAM5, a mitochondrial protein, which was crucial for necroptosis of the myotubes. PF1801 promoted the degradation of PGAM5 through ubiquitin‐proteasome activity. Furthermore, PF1801 suppressed FASLG‐induced reactive oxygen species (ROS) accumulation in myotubes, also crucial for the execution of necroptosis, thorough up‐regulating the antioxidant molecules including Nfe2l2, Hmox1, Gclm, and Nqo1.ConclusionsGLP‐1R agonist could be a novel therapy for PM that recovers muscle weakness and suppresses muscle inflammation through inhi biting muscle fibre necroptosis.

项与 Froniglutide 相关的新闻（医药）

2024-08-13

·Pharmaceutical Technology

GLP-1 receptor agonists cut risk of death in inflammatory disease patients, says study

Patients with immune diseases and type 2 diabetes taking GLP-1RAs had a lower chance of death compared to those taking DPP-4is. Credit: Buravleva stock via Shutterstock. Certain diabetes medications such as Novo Nordisk ’s Ozempic (semaglutide) reduced the risk of death and heart attacks in patients with immune-mediated inflammatory diseases (IMIDs), who also have type 2 diabetes (T2D). Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - Froniglutide [Inn] in Polymyositis Reports LOA and PTSR Model - DD-01 in Type 2 Diabetes Data Insights The gold standard of business intelligence. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The study, conducted by Arthritis Research Canada, analysed electronic health records from 10,855 adult patients with various autoimmune diseases and T2D taking either glucagon-like peptide-1 receptor agonists GLP-1RAs or dipeptidyl peptidase 4 inhibitors (DPP-4i) in British Columbia over two years. Those who took GLP-1RAs had fewer major cardiovascular events (MACE) and deaths compared to those taking DPP-4i, a common type of T2D medication. For every 1,000 people, 8.5 deaths occurred in the group on GLP-1RAs, versus 17.9 in the cohort with DPP-4i. This means that the risk of dying was about half as high with GLP-1RAs compared to DPP-4i’s. IMIDs such as rheumatoid arthritis, psoriasis, and lupus, often cause chronic inflammation that can damage blood vessels and increase the risk of heart disease. This inflammation can also contribute to insulin resistance, a key factor in developing T2D. GLP-1RAs mimic the effects of the GLP-1 hormone, helping to regulate appetite and blood sugar levels. Novo Nordisk and Eli Lilly are the two biggest players in the space, with many other pharma companies jumping on the bandwagon. See Also: Madrigal plans to solidify Rezdiffra’s position in MASH despite start being slower than expected Pfizer touts positive topline data for RSV vaccine Abrysvo Novo Nordisk’s semaglutide is marketed as Ozempic for T2D, and Wegovy for obesity. Eli Lilly’s tirzepatide is called Mounjaro when packaged as a medication for diabetes, and Zepbound for weight loss. The GLP1-RA market is booming , with Lilly’s Mounjaro and Novo’s Ozempic pulling in $5.16bn and $13.9bn in 2023 respectively, according to the respective companies’ financials. The companies are now looking for expanded labels to increase the reach of the blockbuster drugs. In March 2024, the US Food and Drug Administration (FDA) approved a label update for Novo’s Wegovy to include its use as a measure to reduce the risk of cardiovascular death, heart attack, and stroke in adults with heart disease who are diagnosed as obese or overweight. However, their effects on individuals with autoimmune diseases have not been thoroughly investigated, as per Arthritis Research Canada, which sponsored the study. The findings suggest that GLP-1-RAs may offer a critical advantage in managing diabetes and cardiovascular risk in patients with inflammatory arthritis, said the principal investigator of the study and senior research scientist with Arthritis Research Canada, Dr Antonio Aviña-Zubieta. In the announcement accompanying the study results, Aviña-Zubieta said: “Given the increased risk of heart disease in this population, the study highlights the potential of GLP-1 receptor agonists as a preferred treatment option for diabetes, paving the way for improved health outcomes and longevity.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. 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疫苗临床结果上市批准临床研究

2024-08-06

·PRNewswire

NeuroBo Pharmaceuticals Announces Joint Research Agreement, Together with Dong-A ST and ImmunoForge to Develop a Long-Acting Once-Monthly Formulation of DA-1726 for the Treatment of Obesity

Collaboration to Leverage ImmunoForge's ELP Platform Technology Which Can Increase the Half-Life of a Drug by up to 200 Times CAMBRIDGE, Mass., Aug. 6, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has signed a joint research agreement, together with Dong-A ST Co. Ltd. and ImmunoForge, to develop a long-acting, once-monthly, formulation of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), utilizing ImmunoForge's long-lasting half-life extension Elastin-Like Polypeptide (ELP) platform technology. Financial terms of the agreement were not disclosed. "The signing of this research agreement, together with our collaboration partners, Dong-A ST and ImmunoForge, is a step toward potentially developing a long-acting formulation of DA-1726 which would enhance patient compliance and ease of administration for the treatment of obesity," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "We are hopeful that ImmunoForge's ELP platform technology may enable the formulation of DA-1726, currently in Phase 1 studies, into a once-monthly injection, allowing us to overcome the current limitations associated with changing peptides, such as DA-1726, into longer-acting forms. We look forward to working closely with both Dong-A ST and ImmunoForge to bring what could be a first-in-class, once-monthly obesity treatment to market." "This agreement with Dong-A ST, one of the top pharmaceutical companies in Korea, and NeuroBo, reaffirms the potential of our ELP platform technology," added Sung-Min Ahn and Kiho Chang, Co-Chief Executive Officers of ImmunoForge. "Our patented, once-monthly, long-acting ELP platform technology has the capability to increase the half-life of a drug by up to 200 times and we look forward to exploring its application to NeuroBo's DA-1726, a highly promising approach for the treatment of obesity." About ImmunoForge ImmunoForge specializes in novel drug development with a broad pipeline, from pre-clinical through Phase 2, based on its patented Elastin-Like Polypeptide (ELP) platform technology, developed by chief technology officer, Dr. Jim Ballance, which has the ability to increase the half-life of a drug by up to 200 times. The company is currently conducting phase 2 clinical trials for Froniglutide, which has already proven to be stable and which is indicated for a range of diseases including Dermatomyositis and Polymyositis, Duchenne Muscular Dystrophy (DMD) and others. Pemziviptadil, a first-in class drug intended to treat cardiomyopathy associated with DMD and cystic fibrosis, is in preparation for the submission of a Phase 2 Investigational New Drug Application (IND) to the U.S. Food and Drug Administration. A number of the company's pipeline candidates have received FDA orphan drug designation. For more information, please visit . About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide and survodutide, while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE NeuroBo Pharmaceuticals, Inc.

孤儿药临床1期临床2期

2023-10-17

·BioSpace

ImmunoForge Doses First Patient in Phase 2 Clinical Trial of Froniglutide for Dermatomyositis/Polymyositis

[17-October-2023] SEOUL, South Korea, Oct. 17, 2023 /PRNewswire/ -- ImmunoForge today announced that it has dosed the first patient in its Phase 2 clinical trial to evaluate the efficacy, safety, and pharmacokinetic properties of Froniglutide in patients with dermatomyositis/polymyositis. Dermatomyositis/polymyositis (DM/PM) is a disease characterized by muscle wasting and muscle weakness that severely impairs quality of life and is currently treated with steroids and immunosuppressive drugs that have many side effects, indicating a significant unmet need for effective therapies. Froniglutide is a weekly GLP-1 receptor agonist biotherapeutic designed to increase muscle mass and strength by directly acting on muscle cells through targeting GLP-1 receptors that are overexpressed in the muscles of patients with DM/PM. It is expected to improve quality of life in DM/PM patients by restoring muscle strength, improving extra-muscular symptoms such as rash, difficulty swallowing, dyspnea, and fever, and to reduce inflammation. There are currently no drugs in development with the same mechanism of action and no therapies that directly act on the muscle. "Froniglutide has a proven safety pro a unique mechanism of action that directly affects muscle cells, and we look forward to seeing its clinical efficacy demonstrated in patients," said Dr. Dae-Hyun Yoo, a professor of rheumatology at Hanyang University, who is the principal investigator of the Phase 2 study. The clinical study is currently enrolling patients at 10 university hospitals in South Korea, including Hanyang University Hospital. ImmunoForge Co. Ltd., a biotechnology company focused on developing new drugs for rare and intractable diseases, has received orphan drug designation from the U.S. FDA for polymyositis and dermatomyositis and developmental orphan drug designation from the South Korean regulatory agency, the Ministry of Food and Drug Safety (MFDS), and holds composition of matter patents and method of use patents for Froniglutide in the treatment of muscle myositis and sarcopenia. Separately, we have received Phase 2 clinical trial approval from the U.S. FDA for Duchenne muscular dystrophy, another potential indication for Froniglutide, and are pursuing joint development. In May, we announced plans to complete a listing on KOSDAQ in 2025 based on our achievements, including completing technology transfer to a global pharmaceutical company for another new drug based on our ELP half-life extension platform technology. Company Codes: Korea:005940

临床2期孤儿药

100 项与 Froniglutide 相关的药物交易

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