EASL

Madrigal Pharmaceuticals Presents Phase 3 MAESTRO-NASH Data During the Opening General Session of the EASL Congress™

Retrieved on: 
Thursday, June 22, 2023

Resmetirom-treated patients showed improvement in all NAS components and fibrosis, with significantly less worsening in fibrosis stage compared with placebo.

Key Points: 
  • Resmetirom-treated patients showed improvement in all NAS components and fibrosis, with significantly less worsening in fibrosis stage compared with placebo.
  • Separate from the general session presentation, Madrigal is presenting a late-breaker poster at EASL 2023 featuring the first analysis of the MAESTRO-NASH biopsy results using artificial intelligence (AI).
  • The results showed highly statistically significant reduction in fibrosis in both resmetirom 80 and 100 mg groups relative to placebo.
  • Madrigal will host an investor event in Vienna with webcast on Saturday, June 24 at 6:30 PM CEST / 12:30 PM ET.

Aligos Therapeutics Presents Data from its Liver Disease Programs at the European Association for the Study of the Liver (EASL) Congress 2023

Retrieved on: 
Wednesday, June 21, 2023

SOUTH SAN FRANCISCO, Calif., June 21, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that the company is presenting several posters collectively highlighting data from its liver disease programs at the European Association for the Study of the Liver (EASL) Congress 2023, taking place in Vienna, Austria, June 21 – 24, 2023.

Key Points: 
  • Notably, the Company’s late breaking poster (LBP-18) highlights promising emerging data from its ongoing Phase 1b study evaluating the oral capsid assembly modulator (CAM-E), ALG-000184.
  • Importantly, ALG-000184 continues to demonstrate a favorable safety and pharmacokinetic (PK) profile over these extended dosing durations.
  • “We are excited to present emerging clinical data from our CHB portfolio of drug candidates at EASL,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics.
  • “The data presented highlights the progress we have made advancing new targeted therapies for multiple liver diseases.

World-Leading Real World Data Registry, TARGET-NASH, Surpasses 7,000+ Enrolled Patients and 500,000+ Months of Patient Follow-Up

Retrieved on: 
Wednesday, June 21, 2023

DURHAM, N.C., June 21, 2023 /PRNewswire/ -- Real world evidence (RWE) leader, Target RWE, today shared updates from its nonalcoholic steatohepatitis (NASH) longitudinal registry of more than 7,000 enrolled patients, representing more than 500,000 patient months of follow up, making TARGET-NASH the most mature dataset following patients with nonalcoholic fatty liver disease (NAFLD) and NASH in the world. Target RWE will be presenting new data from its TARGET-NASH and TARGET-HCC cohorts at the annual EASL Congress in Vienna, Austria June 21-24th, including disease progression and results from a post-authorization safety study.

Key Points: 
  • Estimating fibrosis progression in patients with NAFLD/NASH is essential for understanding the comprehensive burden of disease, risk of future liver-related morbidity and to inform future clinical trial designs.
  • Progression outcomes included all-cause mortality, progression from non-cirrhosis to cirrhosis and from compensated to decompensated cirrhosis, and liver-related and cardiovascular events.
  • "Identifying patient profiles in the real world who may benefit from these novel treatments will be critical.
  • Real world evidence from the TARGET-NASH cohort has been presented and published in numerous peer-reviewed journals and major academic conferences.

Vaccitech to Present Positive Final Data at EASL Congress for Phase 1b/2 HBV002 Study in Adults with Chronic Hepatitis B

Retrieved on: 
Wednesday, June 21, 2023

HBV002 (NCT04778904) is a Phase 1b/2a clinical trial of VTP-300 in adults with chronic Hepatitis B (CHB).

Key Points: 
  • HBV002 (NCT04778904) is a Phase 1b/2a clinical trial of VTP-300 in adults with chronic Hepatitis B (CHB).
  • “An effective immune response is likely to be essential to controlling chronic Hepatitis B,” said Meg Marshall, Vaccitech’s Chief Medical Officer.
  • VTP-300, encoding Hepatitis B virus (HBV) genotype C antigens, led to a decline in HBsAg in the majority of people infected with genotypes B and C viruses.
  • “Demonstrating cross-reactivity to genotypes B and C in participants, as well as to A-E in healthy subjects, is a promising step to being able to address chronic Hepatitis B infection in as many people as possible.”

Virion Therapeutics Presents VRON-0200 Preclinical Data Showing Direct Correlations Between Intrahepatic CD8+ T cells and Hepatitis B Virus Declines (HBV) at EASL 2023

Retrieved on: 
Wednesday, June 21, 2023

These data were recognized as one of the Top 77 posters (out of 1,700 plus presentations) by the meeting organizers.

Key Points: 
  • These data were recognized as one of the Top 77 posters (out of 1,700 plus presentations) by the meeting organizers.
  • Chronic HBV infection impairs CD8+ T cell functions resulting in the loss of virus control.
  • That makes VRON-0200 so promising," said Hildegund Ertl, MD, Professor, Vaccine & Immunotherapy Center, at The Wistar Institute in Philadelphia PA and Scientific Founder of Virion Therapeutics.
  • The above presentation is available via the EASL-ILC Meeting Site at: https://www.easlcongress.eu , and on Virion's website at https://www.viriontx.com/science/presentations-publications/ .

HistoIndex Presents Advancements in AI-powered Stain-free Tissue Imaging for NASH Clinical Trials at EASL Congress 2023

Retrieved on: 
Wednesday, June 21, 2023

SINGAPORE, June 21, 2023 /PRNewswire/ -- HistoIndex today announced that the Company, alongside its collaborators, will present new data on its novel stain-free tissue imaging technology using clinically validated artificial intelligence (AI) algorithms at the EASL Congress, taking place June 21-24, 2023. The data demonstrate how HistoIndex's stain-free Second Harmonic Generation/Two-Photon Excitation (SHG/TPE) imaging and AI technologies can be used in preclinical through late-stage clinical development to quantify and analyze morphological features of liver biopsy samples across Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD). HistoIndex's patented imaging technology and methodologies will be featured in 14 accepted abstracts, including one oral presentation by Dr. Timothy J. Kendall.

Key Points: 
  • HistoIndex's patented imaging technology and methodologies will be featured in 14 accepted abstracts, including one oral presentation by Dr. Timothy J. Kendall.
  • The studies presented at the EASL Congress demonstrate the successful application of SHG/TPE imaging technology combined with AI analysis in multiple clinical trials focused on NASH and NAFLD.
  • In contrast to manual assessments of stained tissue biopsies and categorical scoring systems, HistoIndex's approach eliminates variability and enhances the accuracy of diagnosis.
  • HistoIndex is participating in the EASL Congress 2023 in Vienna and will be hosting a brunch meeting on 23rd June 2023 from 10.30 am – 12 pm CET to discuss the use of stain-free digital pathology and AI as endpoints in NASH clinical trials.

Assembly Biosciences Presents New Data Highlighting Entry Inhibitor and Core Inhibitor Programs at EASL’s International Liver Congress™ 2023

Retrieved on: 
Wednesday, June 21, 2023

“We are excited to share the latest data on our promising HDV/HBV entry inhibitor program and next-generation HBV core inhibitors with the scientific community,” said William Delaney, PhD, chief scientific officer of Assembly Bio.

Key Points: 
  • “We are excited to share the latest data on our promising HDV/HBV entry inhibitor program and next-generation HBV core inhibitors with the scientific community,” said William Delaney, PhD, chief scientific officer of Assembly Bio.
  • “Data presented from our entry inhibitor program, from which we expect to nominate a development candidate this year, highlight our rapid progress in developing a small molecule inhibitor of this validated mechanism.
  • ABI-H3733 (3733) and ABI-4334 (4334) are novel, structurally distinct, orally bioavailable investigational core inhibitors that exhibit nM potency against pgRNA encapsidation and covalently closed circular (ccc)DNA formation.
  • Subsequent to presentation at EASL’s International Liver Congress™ 2023, Assembly Bio intends to make the posters available on the “Events & Presentations” page in the “Investors” section of its website at www.assemblybio.com .

Boston Pharmaceuticals Announces Positive Phase 2a Results from Monthly and Bi-weekly Dosing with Investigational BOS-580 NASH Program at EASL 2023

Retrieved on: 
Wednesday, June 21, 2023

Boston Pharmaceuticals today announced positive Phase 2a results for BOS-580, its investigational, proprietary, long-acting fibroblast growth factor 21 (FGF21) analog for the treatment of non-alcoholic steatohepatitis (NASH).

Key Points: 
  • Boston Pharmaceuticals today announced positive Phase 2a results for BOS-580, its investigational, proprietary, long-acting fibroblast growth factor 21 (FGF21) analog for the treatment of non-alcoholic steatohepatitis (NASH).
  • The study suggested promising results for monthly and bi-weekly doses of BOS-580, which achieved statistically significant reduction in liver fat content, an exploratory endpoint in the trial of phenotypic NASH patients.
  • Statistically significant reductions in additional exploratory endpoints, including biomarkers of liver injury and fibrosis, were also observed.
  • The most common adverse events in this Phase 2a trial were gastrointestinal, and included nausea, vomiting, and diarrhea.

Arbutus Presents Preliminary AB-729 and Pegylated Interferon Alfa-2a Combination Data at the EASL Congress 2023

Retrieved on: 
Wednesday, June 21, 2023

WARMINSTER, Pa., June 21, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced that preliminary data from its on-going Phase 2a clinical trial evaluating the safety, tolerability and antiviral activity of the combination of AB-729, the Company’s lead RNAi therapeutic, and pegylated interferon alfa-2a (IFN) in patients with chronic hepatitis B virus (cHBV) was presented today at the European Association for the Study of the Liver (EASL) Congress. The preliminary data suggests that the addition of IFN to AB-729 treatment was generally well tolerated and appears to result in continued HBsAg declines in some patients.

Key Points: 
  • The preliminary data suggests that the addition of IFN to AB-729 treatment was generally well tolerated and appears to result in continued HBsAg declines in some patients.
  • William Collier, President and Chief Executive Officer of Arbutus, commented, “These data continue to support our strategy of utilizing AB-729 as a cornerstone in a combination therapeutic for patients with cHBV.
  • HBsAg levels
  • Three patients have been evaluated to stop NA treatment to date, with one meeting the protocol-defined criteria to stop NA treatment.

Sequana Medical announces additional data on safety, quality of life and survival from North American pivotal alfapump® study (POSEIDON)

Retrieved on: 
Wednesday, June 21, 2023

Together with the positive primary endpoint data reported previously, these results further support the clinical benefits of the alfapump and show a survival rate that compares favorably to literature.

Key Points: 
  • Together with the positive primary endpoint data reported previously, these results further support the clinical benefits of the alfapump and show a survival rate that compares favorably to literature.
  • Renal function is often impaired in patients with advanced cirrhosis and patients with evidence of renal failure were excluded from the study.
  • Sequana Medical management will host a conference call with a live webcast presentation today at 15:00 CEST / 09:00 am EST.
  • The webcast and conference call will be conducted in English and a replay will be available on Sequana Medical’s website shortly after.