Fatty liver disease

Inventiva announces the positive recommendation of the third DMC of the Phase III clinical trial with lanifibranor in patients with NASH

Retrieved on: 
Monday, December 4, 2023
NASH, Euronext Paris, DMC, Clinical trial, Fatty liver disease, Data monitoring committee, Patient, Safety, Fibrosis, Pharmaceutical industry

The DMC, composed of a group of independent experts, arrived at this recommendation after review of the safety data of patients enrolled in the NATiV3 trial.

Key Points: 
  • The DMC, composed of a group of independent experts, arrived at this recommendation after review of the safety data of patients enrolled in the NATiV3 trial.
  • The DMC review supports the continuation of the NATiV3 clinical trial, in the absence of a  safety signal that would require any modification to the trial protocol.
  • This safety assessment was based on the review of safety data from more than 500 patients, including patients that have been treated with lanifibranor for more than 72 weeks.
  • This positive recommendation confirms the good safety and tolerability profile of lanifibranor.

Polaris Group Announces First Patient Successfully Dosed with ADI-PEG 20/Placebo in Phase 2a Non-Alcoholic Steatohepatitis (NASH) Study

Retrieved on: 
Thursday, November 30, 2023
NASH, Fatty liver disease, Disease, SAN, Metabolic syndrome, DSM-IV codes, Public, Obesity, Patient, Liver disease, Safety, Pharmaceutical industry

TAIPEI, Taiwan and SAN DIEGO, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550), today announced that the first patient was successfully dosed in the Phase 2a clinical study for Non-Alcoholic Steatohepatitis (NASH).

Key Points: 
  • TAIPEI, Taiwan and SAN DIEGO, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550), today announced that the first patient was successfully dosed in the Phase 2a clinical study for Non-Alcoholic Steatohepatitis (NASH).
  • With limited treatment options available, Polaris Group is committed to developing innovative therapies to address this unmet medical need.
  • "We are excited to reach this pivotal moment in our NASH program," said Howard Chen, Chairman and CEO at Polaris Group.
  • Polaris Group is committed to advancing innovative treatments, and this milestone underscores our dedication to improving patient outcomes."

Algernon Pharmaceuticals Receives Notice of Intention to Grant from Chinese Patent Office for Repirinast to Treat NASH and NAFLD

Retrieved on: 
Thursday, November 30, 2023
NAFLD, Risk, NASH, Fatty liver disease, AGN, Type, Inflammation, Standard of care, Patent, Insulin resistance, Laboratory, Obesity, Patient, Telmisartan, Steatosis, Fibrosis, UUO, CKD, Pharmaceutical industry

The invention claims treating lobular inflammation and nonalcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast.

Key Points: 
  • The invention claims treating lobular inflammation and nonalcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast.
  • The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection.
  • The Company was recently issued patents for Repirinast in NASH from the U.S. and Japan, and has also filed corresponding patent applications in Canada and Europe.
  • “We are pleased to receive this notice of intent to grant from the Chinese Patent Office,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals.

Terns Pharmaceuticals to Present at the JMP Securities Hematology and Oncology Summit

Retrieved on: 
Wednesday, November 29, 2023
Webcast, Hematology, Fireside, Fatty liver disease, NASH, Obesity

FOSTER CITY, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), today announced that members of management will be participating in a fireside chat at the JMP Securities Hematology and Oncology Summit.

Key Points: 
  • FOSTER CITY, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), today announced that members of management will be participating in a fireside chat at the JMP Securities Hematology and Oncology Summit.
  • Details are as follows:
    A live webcast of the Fireside Chat will be available on the investor relations page of the Terns Pharmaceuticals website at http://ir.ternspharma.com .
  • A replay of the webcast will be archived on Terns’ website for at least 30 days following the presentation.

Hepion Pharmaceuticals to Present at the 7th Obesity & NASH Drug Development Summit

Retrieved on: 
Tuesday, November 28, 2023
HEPA, NASH, Drug development, Multiomics, Conditional sentence, Doctor of Philosophy, Obesity, Artificial intelligence, AI, Fatty liver disease, Machine learning, Medical device

EDISON, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that it will present at the 7th Obesity & NASH Drug Development Summit taking place November 27 – 29, 2023 in Boston.

Key Points: 
  • EDISON, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that it will present at the 7th Obesity & NASH Drug Development Summit taking place November 27 – 29, 2023 in Boston.
  • Scott Campbell, PhD, Hepion’s Quantitative Translational Pharmacologist, will deliver an oral presentation on the use of AI / machine learning (“ML”) to enrich NASH clinical trials and for NASH patient selection; and the use of multi-omics with ML for biomarker response prediction.
  • Using AI/ML and Multi-Omics to Determine Efficacy for Clinical NASH Study Enrichment: Highlights from Recently Completed Phase 2 Trials with Rencofilstat

Sagimet Biosciences Announces Oral Presentation of Preclinical Results of FASN Inhibitor in Combination with Semaglutide at the 7th Obesity and NASH Drug Development Summit

Retrieved on: 
Tuesday, November 28, 2023
AASLD, NASH, Drug development, Biopsy, Fatty liver disease, Liver, SAN, Syndrome, Obesity, FASN, Artificial intelligence, Patient, Fibrosis, Pharmaceutical industry

SAN MATEO, Calif., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways, will present preclinical data at the 7th Obesity and NASH Drug Development Summit on November 28, 2023, in Boston.

Key Points: 
  • SAN MATEO, Calif., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways, will present preclinical data at the 7th Obesity and NASH Drug Development Summit on November 28, 2023, in Boston.
  • The presentation details an evaluation of Sagimet’s FASN inhibitor alone or in combination with semaglutide in a preclinical mouse model of nonalcoholic steatohepatitis (NASH), using an artificial intelligence (AI) based digital pathology platform (FibroNestTM, Pharmanest Inc., Princeton, USA) to assess fibrosis.
  • “We are pleased to report strong preclinical combination results demonstrating that the FASN inhibitor alone, not semaglutide, was responsible for significant reduction of liver fibrosis, a predictor of outcome in NASH,” said Eduardo Bruno Martins, M.D., D.Phil., Sagimet’s Chief Medical Officer.
  • ET on Tuesday, November 28, 2023
    The presentation will be available in the “Posters and Publications” section of Sagimet’s website.

Madrigal Pharmaceuticals Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, November 27, 2023
Fatty liver disease, Senior, Employment, Therapy, NASH

The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The equity awards were granted as inducement material to Ms. Huntsman’s and the other employees’ acceptance of employment with the company.
  • Ms. Huntsman received options to purchase 10,077 shares of Madrigal’s common stock, and 7,834 time-based restricted stock units.
  • All such restricted stock units vest in a 25% increment on each of the first through fourth anniversaries of the grant date.

89bio Announces New Positive Long-Term Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH)

Retrieved on: 
Monday, November 27, 2023
Patient, Liver, NASH, Fatty liver disease, SAN, Cirrhosis, QW, Inflammation, Week, FGF21, Fibrosis

SAN FRANCISCO, Nov. 27, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced positive topline data from the blinded extension phase of its Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH). At week 48, both the 30mg weekly (QW) and 44mg every-two-week (Q2W) dosing schedules of pegozafermin demonstrated statistically significant improvements across key markers of liver health. The benefits observed at week 48 were consistent with the results observed at week 24, indicating sustained benefits over time.

Key Points: 
  • The benefits observed at week 48 were consistent with the results observed at week 24, indicating sustained benefits over time.
  • A subset of patients in the placebo arm of the Main Study (n=19) were re-randomized to receive pegozafermin 30mg weekly (QW) during the Extension Phase.
  • The efficacy endpoints assessed in the Extension Phase included liver fat, non-invasive markers of fibrosis and inflammation, and metabolic markers.
  • Extension Phase Data at Week 48: Liver NITs Results [marker of]

Madrigal Pharmaceuticals Appoints Ronald Filippo as Chief Information Officer

Retrieved on: 
Tuesday, November 21, 2023
Digital, Commercial, NASH, Fatty liver disease, Robotics, Schering-Plough, Information system, Thomas Jefferson University, Quality, COVID-19, Teva Pharmaceuticals, Growth, Patient, Head, Therapy, Automation, Information technology

CONSHOHOCKEN, Pa., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Ronald Filippo has been appointed Chief Information Officer.

Key Points: 
  • CONSHOHOCKEN, Pa., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Ronald Filippo has been appointed Chief Information Officer.
  • Bill Sibold, Chief Executive Officer of Madrigal, stated, “Ron’s skillset and depth of digital experience will be a tremendous asset for Madrigal as we prepare for a first-to-market launch of resmetirom.
  • Mr. Filippo began his career in the biopharmaceutical industry at Schering-Plough, supporting information technology operations in R&D and Quality.
  • Mr. Filippo stated, “I look forward to working with the Madrigal team to enhance the company’s information technology and AI capabilities during a pivotal period of growth and transformation.

Inventiva reports 2023 Third Quarter Financial Information¹

Retrieved on: 
Tuesday, November 21, 2023
Sino Biopharmaceutical Limited, NASH, Euronext Paris, Investigational New Drug, Fatty liver disease, EIB, DSM-IV codes, IP, Type 2 diabetes, Patient, European Investment Bank, BofA Securities, Acceleration, Pharmaceutical industry

Net cash used in operating activities amounted to (€69.0) million in the first nine months of 2023, compared to (€40.1) million for the same period in 2022.

Key Points: 
  • Net cash used in operating activities amounted to (€69.0) million in the first nine months of 2023, compared to (€40.1) million for the same period in 2022.
  • R&D expenses for the first nine months of 2023 were up 86 % compared to the same period in 2022.
  • The Company’s revenues for the first nine months of 2023 amounted to €1.9 million, stable from the first six months of 2023, compared to €0.1 million for the same period in 2022.
  • Inventiva has exercised the option to acquire 30% of the shares Hepalys Pharma for the price of 300 yen.