DNL

Sagimet Biosciences Announces Positive Topline Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH

Retrieved on: 
Monday, January 22, 2024
Artificial intelligence, Patient, Cirrhosis, Fibrosis, SAN, University, AI, NAS, Division, LDL, Hepatology, Liver, FDA, Inflammation, NASH, FASN, ALT, Biopsy, DNL

SAN MATEO, Calif., Jan. 22, 2024 (GLOBE NEWSWIRE) --  Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced positive topline results from its FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed non-alcoholic steatohepatitis (NASH) patients with stage 2 or stage 3 fibrosis (F2/F3) at week 52. In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS, and ≥2-point reduction in NAS without worsening of fibrosis. Denifanstat-treated patients also showed statistically significant fibrosis improvement by ≥ 1 stage with no worsening of NASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo.

Key Points: 
  • “Denifanstat is designed to reduce the three main drivers of NASH, including fat accumulation, inflammation, and fibrosis, both independently and in parallel.
  • “Sagimet is committed to creating novel approaches to target dysfunctional metabolic pathways, and we believe these positive results represent a major advancement in that endeavor.
  • “Denifanstat is the only FASN inhibitor currently in clinical development for the treatment of NASH with related fibrosis.
  • Moreover, the safety profile supports the further development of denifanstat in NASH patients.”

Sagimet Biosciences Announces Completion of Enrollment of 120 Patients for Phase 3 Clinical Trial by Its Partner Ascletis of Denifanstat Combined with Bevacizumab for Treatment of Recurrent Glioblastoma

Retrieved on: 
Wednesday, September 27, 2023
Bevacizumab, Therapy, DNL, NASH, Progression-free survival, De novo, PFS, Glioblastoma, Patient, SAN, Decompression (diving), FASN, Liver, Biopsy, Pharmaceutical industry

Ascletis anticipates that this number of study subjects will provide sufficient events for its planned interim analysis of progression-free survival (PFS).

Key Points: 
  • Ascletis anticipates that this number of study subjects will provide sufficient events for its planned interim analysis of progression-free survival (PFS).
  • Denifanstat is an oral, selective small molecule inhibitor of fatty acid synthase (FASN), a key enzyme which regulates de novo lipogenesis (DNL).
  • Sagimet also expects to report Phase 1 clinical trial results characterizing the pharmacokinetic profile of denifanstat in patients with impaired hepatic function in the first quarter of 2024.
  • “We congratulate Ascletis on achieving this important patient enrollment milestone in its Phase 3 clinical trial of denifanstat being conducted in China in patients with recurrent glioblastoma,” stated David Happel, Chief Executive Officer of Sagimet.

OrsoBio Announces Presentation of Five Abstracts at AASLD’s The Liver Meeting® 2022 Highlighting Programs for Severe Metabolic Disorders

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Thursday, November 3, 2022
Health, Infectious Diseases, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Doctor of Philosophy, Abstract (summary), Associate, Research, Phase 1, 2021 Essex County Council election, Weight loss, Liver, Custom, Lipogenesis, Cincinnati, Respiration (physiology), Mouse, NASH, Safety, Pharmacokinetics, AMPK, IPSC, Non-alcoholic fatty liver disease, Northwest Hospital & Medical Center, Lipotoxicity, Liver X receptor, Patient, Institute of Liver and Biliary Sciences, TCA, AASLD, Pediatrics, Translation, Hepatocyte, Oxidative stress, Plasma, Dyslipidemia, Gilead Sciences, GCKR, De novo, DNL, Foundation, LDL, Tryptophan, Fatty liver disease, Center, Acquired generalized lipodystrophy, Lipid metabolism, Gene, Insulin resistance, Primate, ABCA1, MD, ABCG1, LXR, Pharmaceutical industry, Medical device, Vaccine, Dietary supplement, Rail profile

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced the presentation of five abstracts from the companys programs at AASLDs The Liver Meeting from November 4-8.

Key Points: 
  • OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced the presentation of five abstracts from the companys programs at AASLDs The Liver Meeting from November 4-8.
  • There remains tremendous unmet medical need for patients with severe metabolic disorders, said Mani Subramanian, MD, PhD, Chief Executive Officer of OrsoBio.
  • I am truly excited about translating the data on OrsoBios compounds in HLOs derived from genetic subsets of patients to clinical studies in patients with severe metabolic disorders.
  • The following abstracts will be presented as poster presentations at The Liver Meeting, in Washington, D.C., November 4-8, 2022.

OrsoBio Announces Acquisition of LXR Inverse Agonist Program for Treatment of Severe Dyslipidemias from Phenex Pharmaceuticals

Retrieved on: 
Wednesday, November 2, 2022
Biotechnology, Diabetes, Health, Pharmaceutical, Clinical Trials, Pharmacology, Entrepreneurship, Liver, MD, Lipogenesis, Plasma, Steatosis, ABCG1, Acquisition, Mouse, Liver disease, Hypertriglyceridemia, Lipoprotein, IPSC, Respiration (physiology), Institute of Liver and Biliary Sciences, NASH, Fatty liver disease, Foundation, DNL, Lipid metabolism, ABCA1, LXR, Patient, GCKR, De novo, Acquired generalized lipodystrophy, Gilead Sciences, Gene, Dyslipidemia, Cholesterol, Abstract (summary), Pharmaceutical industry, Gum arabic, Dietary supplement, Doctor of Philosophy, Liver X receptor, Rail profile

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced its acquisition of assets relating to the Liver X Receptor (LXR) inverse agonist program from Phenex Pharmaceuticals, including lead candidate TLC-2716 and associated intellectual property.

Key Points: 
  • OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced its acquisition of assets relating to the Liver X Receptor (LXR) inverse agonist program from Phenex Pharmaceuticals, including lead candidate TLC-2716 and associated intellectual property.
  • Our Phase 1 study is progressing well, and we look forward to the continued development of TLC-2716 for the treatment of severe dyslipidemias in 2023.
  • I am truly excited that OrsoBio is progressing TLC-2716 into the clinic to unlock the potential of this first-in-class compound for patients with severe dyslipidemias.
  • OrsoBio, Inc. is a privately held, clinical-stage biopharmaceutical company dedicated to developing therapies to treat severe metabolic disorders, including type 2 diabetes, severe dyslipidemias, lipodystrophies, and nonalcoholic steatohepatitis.

Ascletis Announces the Latest Results of the Preclinical Studies of Two Novel Anti-Cancer Drug Candidates, ASC61 and ASC60, to be presented at AACR Annual Meeting 2022

Retrieved on: 
Sunday, March 27, 2022
Pegasys, Company, Cornerstone, Hepatitis B virus, Syngenic, Metabolism, Center for Drug Evaluation and Research, Mass flow (life sciences), CHB, National Medical Products Administration, Acne, Compliance, GBM, AACR, Gannex, Research, Mab, CEO, RNA, Food, NMPA, PD-1, RNA polymerase II, PBC, FXR, NASH, Center, HIV/AIDS, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, FASN, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DNL, Hepatitis C, Degenerative disease, THR, R, De novo, CDE, FDA, Bevacizumab, PD-L1, Patient, Phase, Hong Kong Stock Exchange, Pharmaceutical industry, Vaccine, Cancer

Preclinical studies showed that ASC61 demonstrated significant antitumor efficacies and were well-tolerated in both syngeneic and humanized tumor mouse models.

Key Points: 
  • Preclinical studies showed that ASC61 demonstrated significant antitumor efficacies and were well-tolerated in both syngeneic and humanized tumor mouse models.
  • ASC61 was found to have favorably comparable antitumor activities as the U.S. Food and Drug Administration (FDA) approved PD-L1 therapeutic monoclonal antibody (mAb), Atezolizumab.
  • ASC60 can disrupt metabolism and tumor-associated signal transduction in tumor cells through inhibition of de novo lipogenesis (DNL).
  • Preclinical studies showed that ASC60 could suppress tumor growth and enhance the antitumor activities of mPD-1 antibody in tumor mouse models.