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    Home > Medical News > Medical World News > NASH research and development has suffered another blow to the 10 billion Blue Sea market on the road.

    NASH research and development has suffered another blow to the 10 billion Blue Sea market on the road.

    • Last Update: 2020-08-03
    • Source: Internet
    • Author: User
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    Text . . . Dopine
    non-alcoholic fatty hepatitis (NASH), also known as metabolic fatty hepatitis, is a clinical syndrome with pathological changes similar to alcoholic hepatitis but no history of excessive drinking, mainly manifested in the liver cell bubbly fat degeneration accompanied by liver cell damage and inflammation, serious cases can develop cirrhosis.
    , about 3-5% of people worldwide have NASH, which is about to become the number one common cause of liver transplantation in the United States after chronic hepatitis C, according to a 2017 article in Nature. Evaluate Pharma, a leading pharmaceutical market research firm, has predicted that the global MARKET for NASH drugs could reach $40 billion by 2025.
    because of the lack of awareness of the pathogenesis of NASH, THE development of NASH drug volume is also a process of crossing the river with a stone. So far, only one drug has been approved worldwide, Zydus Cadila's Saroglitazar, a double agonist of PPAR alpha/PPAR, which was approved in India in February for the treatment of NASH, and in India, which has been approved for the treatment of diabetic lipid abnormalities and triglycerides in patients with type 2 diabetes that are not controlled by statins.
    in addition to Zydus Cadilla, there are a number of enterprises at home and abroad layout NASH field. However, the development of NASH drugs has not been easy, there are many drugs are now in line. Unfortunately, on June 29th Intercept Pharma's FXR agonisant Ocaliva's application for the treatment of NASH hepatic fibrosis was rejected by the FDA, the first NASH drug to be successful in Phase 3 clinical trials to date, and the news has undoubtedly cast another shadow over NASH drug development. Today, the author takes stock of the progress of NASH drug research in recent years based on the smoothness of clinical trials.. In June 2020, Inventiva announced that lanifibranor had reached the primary and secondary endpoint in an IIb clinical trial called NATIVE. NATIVE is a randomized double-blind, placebo-controlled, parallel distribution, dose range, multicenter 2b clinical study designed to assess the efficacy and safety of two consecutive weeks of USE of IVA337 (800 mg, 1200 mg) per day compared to placebo in adult NASH patients with hepatic fat degeneration and moderate to severe necrosis inflammation but no cirrhosis.
    data show that in the 24-week clinical trial, lanifibranor reached the primary endpoint of the trial. In the patient population receiving the treatment of lanifibranor at a dose of 1200 mg/d, the score of liver cell inflammation and hepatocellular balloon-like variation was significantly lower than that of the baseline (while the degree of hepatic fibrosis did not deteriorate). 49% of patients in the Lanifibranor treatment group (1200 mg/d) reached this end point, while the number in the placebo group was 27% (p-0.004). in addition,
    , lanifibranor reached several secondary endpoints of the trial, including: 1) no fibrosis deterioration in two dose groups (800 mg/d and 1200 mg/d) and 2) fibrosis improved by at least one stage in the 1200 mg/d dose group, and 3) two dose groups (800 mg/d and 1200 mg/d) and no deterioration in NASH.
    Novo Nordisk, announcing its first quarter 2020 results, said Somarutide had achieved positive results in Phase II clinical trials for the treatment of NASH. Somarutide significantly eliminates the patient's NASH histological symptoms without exacerbating liver fibrosis compared to placebo.
    in addition, Thesamarutide in conjunction with Gilead in the research therapy acetyl coenzyme A cariumnease (ACC) inhibitor firsocostat and faniol X receptor agonis cilofexor treatment NASH Phase II clinical trial is also expected to be the results in the near future.
    April 2020, a two-blind, placebo-controlled Phase II clinical trial that evaluated the efficacy and safety of namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD) and NASH reached the primary end of the study. The study ended with changes in ALT and AST levels, liver fat percentages, liver hardness, and the researchers received a total of 12 weeks of treatment and followed up until the 16th week.
    trial data showed a decrease in dose-dependent levels in alT and AST levels in the treatment group compared to the placebo group, indicating a reduction in liver inflammation. At week 16 follow-up, the percentage of patients in the 25 mg dose group who returned to normal levels of ALT was 36.8%, and 23.8% in the 12.5 mg dose group, compared with 10% in the placebo group.
    early April 2020, a randomized, double-blind, comfort-controlled Phase 2a clinical trial of AKR-001 treatment OF NASH reached the end of Week 12.
    data show that in the 12th week of treatment, the absolute level of liver fat in all Patients in the AKR-001 dose group was significantly reduced from the baseline, reaching the primary endpoint of the trial. All AKR-001 dose groups reached secondary endpoints with relative reductions in liver fat, with a relative reduction of more than 70% in both 50 mg and 70 mg dose groups.
    recently, Akero published results from the 16-week Balanced trial: 48 percent of patients at three doses improved at least level 1 fibrosis, 28 percent improved level 2 fibrosis, compared with 0 in the control group (although only two had biopsy data); The proportion of patients in the drug group who also improved primary fibrosis and the disappearance of inflammation was 28%. Notably, the news sent Akero up 50% after the close.
    November 2019, The Lancet published the clinical results of the second phase of Resmetirom's treatment of NASH - patients in the Resmetirom group had a significanter reduction in liver fat at 12 weeks (-32.9% vs -10.4%) and 36 weeks (-37.3% vs -8.5%).
    May 2019, St. Juntai announced that HTD1801 had reached the primary endpoint and several important secondary endpoints in a Phase IIa clinical trial for the treatment of patients with type 2 diabetes NASH, and that the data showed that HTD1801 not only significantly reduced liver fat content, HbA1c, ALT and GGT levels, but also improved lipids and weight. In addition, the drug has been developed for the treatment of primary sclerosing bile ductitis (PSC), and in the United States, the drug has been certified by the U.S. FDA for both NASH and PSC indications, as well as for the treatment of PSC orphans.
    at the 28th Annual Meeting of the Asia Pacific Society of Hepatology in 2019, the Tacke team reported the results of The IIb Clinical Study (CENTAUR) for Cerivnico's treatment of adult NASH and hepatic fibrosis - Cenicifiroc is well tolerated, and after one year of treatment, the majority of subjects had improved liver fibrosis compared to the placebo group, with no worsening of fatty hepatitis, and patients with higher levels of activity and disease. In 2015, the FDA qualified the drug for fast-track reviews to improve NASH and liver fibrosis.
    the 2018 Phase 2b clinical trial of aramchol for NASH, which achieved positive results to meet fda regulatory approval, galmed announced in October 2019 that it would initiate a Phase 3/4 ARMOR clinical study of aramchol treatment NASH to assess the effectiveness and safety of the drug in non-alcoholic fatty hepatitis (NASH) and fibrosis patients.
    Aldafermin is a non-tumor-based protein engineering variant of fibroblast growth factor 19 (FGF19) that significantly reduces liver fat content and improves liver function by targeting a variety of disease-causing pathways in NASH. In October 2019, the drug reached the primary endpoint of the trial in the mid-term analysis of the fourth line of phase 2 clinical trials, with 72% of patients having an absolute liver fat (LFC) content decreased by at least 5%. In addition, the drug showed the potential to improve the biomarkers ALT, AST, and patient liver fibrosis marker PRO-C3 (N-end III collagen prepeptides) in PATIENTs with NASH patients.
    March 2019, Viking announced positive results from a Phase 2 study to assess the efficacy, safety, and tolerance of Patients with Elevated LDL-C treatment of VK2809, which showed that VK2809 significantly reduced LDL-C and liver fat levels in patients after 12 weeks of treatment compared to placebos.. In May 2020, Genfit announced that elafibranor had failed to achieve the primary endpoint in the Phase III control study RESOLVE-IT of 1070 patients with Phase 2 or 3 fibrosis.
    72-week efficacy data showed that 19.2% of patients in the elafibranor drug group reached the primary endpoint of NASH decline and no exacerbation of fibrosis, compared with 14.7% in the placebo group. 24.5% of patients in the elafibranor drug group achieved a secondary endpoint of improved fibrosis at least one level, compared with 22.4% in the placebo group. The announcement led to a 68% drop in Genfit's stock.
    November 2019, Cirius Therapeutics announced that MSDC-0602K significantly improved liver enzyme levels, blood glucose control, and insulin resistance in a 2b trial for NASH patients. In January 2020, however, Cirius Therapeutics announced that it was withdrawing its previous $86 million IPO application because its Phase II clinical trials did not reach the primary endpoint.
    June 2019, Novartis and Conatus Pharmaceuticals announced that encore-LF had not reached the primary endpoint in the Phase II b study of Emricasan (VAY785) for NASH. The results showed no significant improvement in event-free survival in the emricasan treatment group compared to the placebo group.
    December 2019, Bollinger Ingham and partner Pharmaxis announced that BI 1467335 had not failed directly in the latest clinical study, but due to its interaction with other drugs, the two decided to abandon the development of the drug for the treatment of fatty liver disease.
    Gilead's decline in NASH drug development, and after a setback in the development of selonsertib, acquired cilofexor and fisocostat, respectively, from Phenex Pharmaceuticals and Nimbus Therapeutics, respectively, but insisted on not getting the desired result, and in December 2019 a comparison of fisocostat, cilofex, the two combinations of drugs and the two failed to achieve a placebo.
    June 2019, Seladelpar treated NASH's Phase IIb clinical trial (NCT03551522) did not reach the primary endpoint - the reduction in liver fat content (LFC) in patients in the Seladelpar treatment group was less than in the placebo group. In addition, in the 10 mg, 20 mg, and 50 mg Seladelpar treatment groups, the proportion of patients with a reduction of lFC by at least 30% was 24%, 25.5% and 18.8%, respectively. At week 12, the Seladelpar treatment group significantly improved biochemical indicators of liver damage compared to placebo, such as alanine amino metase (ALT), tthaneline amino metase (AST), glutamine transferase (GGT) and alkaline phosphatase (AP).
    discontinued the trial because of the potential risk of liver damage, then Cymabay issued a statement saying it would restart the NASH IIb clinical study of Seladelpar because the independent panel agreed that there was no clinical, biochemical or histological evidence in the clinical trial that seladelpar induced liver damage.
    , currentLY NASH drugs are classified as FXR receptor agonists, TR beta agonists, FGF19 agonists and PPAR agonists (of which FXR receptor agonists include Ocaliva, cilofexor, TR beta agonists including Resmetirom, VK2809, PPAR agonists).
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