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On August 27-29, 2020, the annual meeting of the European Society of Hepatology (EASL) and the Digital International Liver Congress (DILC) was held as an online conference, the first annual event held by EASL in the form of a "digital conference" to attract scientific and medical experts from all over the world to learn about the latest developments in liver research and to exchange clinical experience.
clinical advances reported at the conference show that two classes of drugs have improved the progression of non-alcoholic fatty hepatitis (NASH) disease with multiple biomarkers.
these studies assessed safety, biomarkers of liver damage, and liver fat, representing the latest developments in a new strategy for treating fatty liver disease, targeting lipid metabolism.
the potential of this strategy in addressing type 2 diabetes (T2DM) and obesity and liver disease makes it the focus of current research.
it is estimated that non-alcoholic fatty liver disease (NAFLD) affects about 25% of the world's population, and NASH is an extreme form of development of NAFLD, defined as the emergence of fatty degeneration associated with inflammation and liver cell damage.
NASH can lead to late-stage liver fibrosis, cirrhosis, liver failure, and liver tumors.
NASH market has reached $40 billion, but no drugs have been approved to treat NASH.
current study focuses on a wide range of pathological pathogenic pathogenes, including lipid metabolism.
estimated that 37.3% of T2DM patients have NASH, so the effects of lipid metabolism and inflammatory liposuction have been the focus of research.
includes the phyniol X-like peptide-1 (GLP-1) subject, which negatively regulates hemolytic sugar, fat production, and fat degeneration, while the latter improves blood sugar control and weight loss by reducing appetite, affecting liver lipid content, and inflammation.
results presented at the conference show that targeting FXR, GLP-1, and gastrointestinal hormones is a promising treatment for NASH and deserves further study.
1, new FXR astrist EDP-305 clinical results: EDP-305 is a new generation of powerful FXR astrists developed by Enanta Pharmaceuticals.
the results of the ARGON-1 study from Phase 2a.
the study, fibrosis NASH patients without cirrhosis were randomly divided into placebo group (n=24), EDP-305 1mg (n=55), EDP-305 2.5mg (n=53) for 12 weeks.
data show that the high-dose EDP-305 group was in the ALT (-27.9 U/L; p-0.0495), fat percentage (-7.1% ;p-0.0009; through magnetic resonance) compared to the placebo group. Imaging proton density fat fraction measurement), gamma-glutamine transferase (-49.4 U/L;p-lt;0.0001), and C4 as a pharmacological marker were significantly reduced (-72%;p-lt;0.001).
high-density lipoproteins were also significantly reduced (-0.21mmol/L;p-lt;0.0001).
itching was the most common adverse event caused by treatment, with 5% and 51% of the subjects in the placebo group, EDP-305 1mg group, and EDP-305 2.5mg group, respectively.
this led to 1.8% of patients in the EDP-305 1mg group and 1.8% and 20.8% of the EDP-305 2.5mg group, respectively.
: In this study, the results confirm that FXR agitation is a valuable therapeutic target of NASH, with strong anti-fatty degeneration effect and the potential to reduce inflammatory damage to the liver.
highlights the need for large-scale and longer-term clinical trials to demonstrate the histological benefits of these drugs at doses with minimal side effects.
2, GLP-1/GC dual-subject agonist cotadutide clinical results: Cotadutide is the first of its kind (first-in-class) gluatic glucosin-like peptide-1/GLP-1/GC dual-subject agonist developed by AstraZenecon.
2b study data were released at the conference.
the study, which included 834 overweight or obese T2DM patients, was designed to assess the overall metabolic effects of cotadutide and to conduct an exploratory analysis of liver biomarkers.
study, patients were randomly assigned a placebo, an open label of 1.8 mg of liraglutide once a day, and a subsurfed injection of cotadutide (100 μg, 200 mg, 300 μg) once a day for 54 weeks of treatment.
at the end of treatment, all cotadutide dose groups had significantly lower body weight (p.001) compared to the placebo group, and the cotadutide 300 sg dose group had significantly lower body weight compared to the liraglutide treatment group (p-0.009).
addition, the cotadutide 200 μg group (-12 U/L, p=0.009) and the 300μg group (-14.1, p=0.003) were significantly reduced compared to the placebo group, the cotadutide 300μg group and the liraglutide treatment group (p=0.023).
results were further confirmed by improvements in the NAFLD fibrosis score (NFS, p=0.01) and FIB-4 (p=0.004) in the cotadutide 300?g group compared to the placebo group.
: In this study, cotadutide had a similar weight loss effect to GLP-1 subject excitant liraglutide at a dose of 200 sg in patients with overweight/obese T2DM, with greater weight and ALT reduction at a dose of 300 sg.
improvements in NFS and FIB-4 are also very encouraging.
data support the need for forward-looking clinical trials of cotadutide in NASH patients.
source: Two novel treatments show promise in improving biomarkers of NASH pathology.