EASL

Drug Farm Announces anti-HBV immunomodulator, DF-006 is Accepted as a Late-Breaking Presentation at the 2024 European Association for the Study of the Liver Conference

Retrieved on: 
Thursday, May 2, 2024
Research, Infectious Diseases, Genetics, Clinical Trials, Cardiology, Biotechnology, Pharmaceutical, Health, Optical, Science, University, EASL, Auckland City Hospital, HBeAg, Safety, Hepatitis, Intelligence, CccDNA, Patient, CHB, Immune system, Infection, HBV, ALPK1

Title: A phase 1, double-blinded, randomized, placebo-controlled, multicenter global study evaluating the safety, tolerability, and antiviral activity of DF-006 in chronic hepatitis B, virologically-suppressed patients.

Key Points: 
  • Title: A phase 1, double-blinded, randomized, placebo-controlled, multicenter global study evaluating the safety, tolerability, and antiviral activity of DF-006 in chronic hepatitis B, virologically-suppressed patients.
  • DF-006 is a first-in-class, orally administered ALPK1 agonist immunomodulator that potently stimulates local, innate immunity in the liver1.
  • DF-006 has a novel mechanism of action that is capable of stimulating the body’s own immune system to help clear the infection.
  • “DF-006 has demonstrated potent antiviral responses in preclinical studies, including inhibition of cccDNA and recruitment of T-cells.

Precision BioSciences Announces Late-Breaking Poster Presentation at the European Association for Study of the Liver (EASL) Congress 2024

Retrieved on: 
Wednesday, May 1, 2024
Technology, Biotechnology, Nanotechnology, Health, Other Health, Pharmaceutical, Stem Cells, Oncology, Research, Infectious Diseases, Genetics, Fitness & Nutrition, Science, Clinical Trials, Congress, CTA, EASL, Gene editing, IND, Entrepreneurship, CccDNA, Precision BioSciences, Precision, HBV

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced that the company will present late-breaking preclinical data from its clinical candidate, PBGENE-HBV, for the treatment of chronic hepatitis B (HBV) during a poster presentation at the European Association for Study of the Liver (EASL) Congress 2024 being held June 5-8, 2024 in Milan, Italy.

Key Points: 
  • Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced that the company will present late-breaking preclinical data from its clinical candidate, PBGENE-HBV, for the treatment of chronic hepatitis B (HBV) during a poster presentation at the European Association for Study of the Liver (EASL) Congress 2024 being held June 5-8, 2024 in Milan, Italy.
  • “We look forward to the opportunity to share the latest new preclinical safety data from our PBGENE-HBV clinical candidate at the EASL Congress,” said Jeff Smith, Co-Founder and Chief Research Officer at Precision BioSciences.
  • PBGENE-HBV is designed to safely eliminate cccDNA and inactivate integrated HBV DNA.
  • As we look ahead, we remain on track to file an investigational new drug (IND) and/or clinical trial application (CTA) in 2024.”
    Presenter: Emily Harrison, Senior Scientist - Hepatitis Research Leader, Precision Biosciences

NeuroBo to Present Latest Pre-Clinical Data on Cardiometabolic Assets, DA-1241 and DA-1726, Targeting MASH and Obesity, at Scientific Conferences in June

Retrieved on: 
Tuesday, April 30, 2024
Contract research organization, American Diabetes Association, GAN, Part, Congress, EASL, Gubra, OXM, Weight loss, GCGR, GLP1R, GPR119, Obesity, SAD, Glucagon-like peptide-1 receptor, MASH, Pharmaceutical industry

"We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Key Points: 
  • "We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
  • DA-1726 has consistently shown, in our preclinical data, to sustain weight loss in diet-induced obese models by decreasing food consumption and boosting energy expenditure.
  • Both programs are progressing well, and we have been able to significantly accelerate the clinical timelines for DA-1726.
  • A member of the Dong-A ST Research Center will present pre-clinical data on DA-1726 in a poster presentation at this scientific session in Orlando, FL.

Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 12, 2024
Research, Hepatitis, CAM, Stop, KU Leuven, AASLD, Annual general meeting, SAN, EASL, MASH, MBA, Hepatology, Investment, Clinical trial, Therapy, Phase II, Interim, ECCMID, Infection, CHB, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2023.
  • R&D expenses for the year ended December 31, 2023, were $73.0 million, compared with $85.1 million for the same period of 2022.
  • G&A expenses for the year ended December 31, 2023, were $30.6 million, compared with $26.4 million for the same period of 2022.
  • Total G&A stock-based compensation expense incurred for the year ended December 31, 2023 was $5.8 million, compared with $6.7 million for the same period of 2022.

Arbutus Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 29, 2024
LNP, HBV, Court, PD, Research, Virology, Expert witness, CFBV, AASLD, Construction, Nivolumab, Investment, Arbutus, HBsAg, EASL, Vaccine, Interim, Safety, COVID-19, Pharmacokinetics, Roivant Sciences, Patient, Clinical trial, Congress, RNA interference, DNA, Pharmaceutical industry

Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.

Key Points: 
  • Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.
  • Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
  • Arbutus is advancing AB-101 into part two of this clinical trial which involves dosing healthy subjects with multiple-ascending doses of AB-101.
  • Roivant Sciences Ltd. owned approximately 23% of the Company’s outstanding common shares as of December 31, 2023.

Medivir to present clinical pharmacokinetic data at EASL Liver Cancer Summit, further supporting the continued development of fostrox

Retrieved on: 
Monday, January 15, 2024
Patient, HCC, Poster, Cancer, EASL, Hepatocellular carcinoma, Liver cancer, Medivir, Pharmaceutical industry

STOCKHOLM, Jan. 15, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that clinical pharmacokinetic (PK) data from the first study with fostroxacitabine bralpamide (fostrox) (NCT03781934) will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit in February 22-24, 2024 in Rotterdam.

Key Points: 
  • STOCKHOLM, Jan. 15, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that clinical pharmacokinetic (PK) data from the first study with fostroxacitabine bralpamide (fostrox) (NCT03781934) will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit in February 22-24, 2024 in Rotterdam.
  • The abstract, titled 'Population pharmacokinetic modeling of orally administered fostroxacitabine bralpamide (fostrox, MIV-818) and its metabolite troxacitabine in a phase I/IIa liver cancer study' will be presented at the conference by Karin Tunblad PhD, Project Director for fostrox at Medivir.
  • The presentation will include pharmacokinetic results from 42 patients in the phase I/IIa clinical study with fostrox monotherapy and the fostrox + Lenvima® combination, supporting regulatory interactions and further strengthening the continued development of fostrox in patients with hepatocellular carcinoma (HCC).
  • The abstract and the poster will be available on Medivir's website after the presentation.

Arbutus Announces 2024 Corporate Objectives and Provides Financial Update

Retrieved on: 
Monday, January 8, 2024
LNP, RNA interference, AASLD, Virology, HBV, Vaccine, Court, Nivolumab, Congress, Clinical trial, Pharmacokinetics, PD, Expert witness, Arbutus, COVID-19, EASL, CFBV, Interim, Investment, Patient, Safety, HBsAg, PD-L1, Pharmaceutical industry

Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.

Key Points: 
  • Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.
  • Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
  • Arbutus expects to report preliminary data from the healthy subject portion of this clinical trial, including target engagement and receptor occupancy data, in the first half of 2024.
  • With respect to the Moderna lawsuit, fact discovery is currently on-going with the claim construction hearing scheduled for February 8, 2024.

Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

Retrieved on: 
Thursday, December 7, 2023
Liver, UDCA, Chapter Two, Woman, FDA, MAA, Fatigue, Nausea, Primary biliary cholangitis, Inflammation, ADR, Patent, Liver disease, Diagnosis, AMF, CHMP, Ascending cholangitis, UCD, Business, ACLF, PDUFA, Itch, Risk, New Drug Application, OA, Common, EASL, MASH, Liver failure, Safety, Ammonia, Elafibranor, Therapy, Epidemiology, History, Patient, Cholangiocarcinoma, Food, Health care, EMA, Ursodeoxycholic acid, MHRA, Cirrhosis, Medicine, NTZ, EVP, Cholestasis, NASH, Research, Diarrhea, Bile, NDA, PBC, Abdominal pain, Clinical trial, European Medicines Agency, IPN, PPAR, P10, CCA, Fibrosis, Pharmaceutical industry

An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.

Key Points: 
  • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • The trial enrolled 161 patients who were randomized 2:1 to receive either elafibranor 80mg once daily or placebo.
  • ELATIVE also investigated the effect of treatment with elafibranor on pruritus (severe itch), a significant symptom burden amongst people living with PBC.
  • Findings from the secondary endpoint using the PBC Worst Itch NRS score, showed a reduction in pruritis for elafibranor, which was not statistically significant.

CymaBay Presents Results on the Potential of Seladelpar in Treatment of Patients with Primary Biliary Cholangitis at ACG 2023

Retrieved on: 
Monday, October 23, 2023
Ethnographic Museum of the University of Zurich, Patient, American College, IL-31, Itch, UDCA, The Duke of Edinburgh's International Award - Canada, Hope, Pathology, Conditional sentence, NRS, Liver, ALP, American College of Gastroenterology, HIV disease progression rates, PBC, Ursodeoxycholic acid, Risk, European Association for the Study of the Liver, Research and development, Cholestatic pruritus, Alkaline phosphatase, Primary biliary cholangitis, University, EASL, Cholestasis, Atopic dermatitis, Therapy, Doctor of Philosophy, Pharmaceutical industry, Research, MD

VANCOUVER, British Columbia, Oct. 23, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, announced today the presentation of findings from its post-hoc analysis of the Phase 3 ENHANCE study of seladelpar for the treatment of primary biliary cholangitis (PBC), showing baseline intensity of patient-reported pruritus was associated with higher levels of serum IL-31. The presentation, named the recipient of this year’s International Award by the American College of Gastroenterology, will be presented by Professor Andreas E. Kremer, MD, Ph.D., MHBA, a leading authority in cholestatic pruritus from the University of Zurich. Featured results included novel aspects of the anti-pruritic and anti-cholestatic mechanisms of seladelpar, CymaBay’s first-in-class oral, selective PPARδ agonist, or "delpar," being investigated for the treatment of patients with PBC.

Key Points: 
  • Featured results included novel aspects of the anti-pruritic and anti-cholestatic mechanisms of seladelpar, CymaBay’s first-in-class oral, selective PPARδ agonist, or "delpar," being investigated for the treatment of patients with PBC.
  • The data were previously presented at the European Association for the Study of the Liver (EASL)’s The International Liver Congress™ 2023 in Vienna, Austria.
  • “These results offer a glimmer of hope in that they link IL-31 levels in patients with PBC to itch.
  • Elevated risk due to ELF was identified in 43.2% of patients who currently meet guidelines for second-line treatment vs. 27.2% within patient groups not recommended for second-line treatment.

Fibronostics Announces Partnership with Stone Diagnostics

Retrieved on: 
Tuesday, October 10, 2023
Partnership, Social prescribing, Guideline, United, Health care, Biomarker, Customer support, Prevalence, AI, ROSA, Liver, Chronic liver disease, AASLD, Rock (geology), Chemistry, Growth, Biopsy, Patient, End organ damage, Steatosis, Fibrosis, DSM-IV codes, Physician, Liver disease, EASL, MAFLD, Medical imaging, Medical device

SANTA ROSA BEACH, Fla. and SINGAPORE, Oct. 10, 2023 /PRNewswire/ -- Fibronostics , a global leader in non-invasive, AI-driven diagnostic testing for *MAFLD/MASH patients, announced today a strategic partnership with Stone Diagnostics, a leading provider of laboratory services in the United States.

Key Points: 
  • SANTA ROSA BEACH, Fla. and SINGAPORE, Oct. 10, 2023 /PRNewswire/ -- Fibronostics , a global leader in non-invasive, AI-driven diagnostic testing for *MAFLD/MASH patients, announced today a strategic partnership with Stone Diagnostics, a leading provider of laboratory services in the United States.
  • Stone Diagnostics will provide Physicians and their patients end to end service to enable Physicians to assess chronic liver disease with Fibronostics' benchmark product, LIVERFASt™.
  • Stone Diagnostics' combination of scaled operational excellence and leading digital capabilities leveraging MyHealthAI is ideal and vital to serve doctors using LIVERFASt™ to screen, identify and monitor *MAFLD/MASH patients.
  • "We are delighted to partner with Stone Diagnostics to provide LIVERFASt™ to the medical community", said Fibronostics CEO Sven Henrichwark.