EASL

Mirum Pharmaceuticals Showcases Five New LIVMARLI (maralixibat) Presentations at the EASL Congress

Retrieved on: 
Friday, June 23, 2023
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Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced data presented during the European Association for the Study of the Liver (EASL) Congress 2023, taking place in Vienna, Austria.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced data presented during the European Association for the Study of the Liver (EASL) Congress 2023, taking place in Vienna, Austria.
  • The congress presentations feature new analyses from the LIVMARLI® (maralixibat) oral solution MARCH-PFIC study as well as the long-term extension study, MARCH-ON.
  • Additionally, data showing LIVMARLI’s benefit in adult patients with Alagille syndrome (ALGS) was presented during EASL.
  • All presentations are available in the Publications and Presentations section on Mirum’s website.

Pliant Therapeutics Presents Data from its Bexotegrast Program at the European Association for the Study of the Liver (EASL) International Liver Congress™

Retrieved on: 
Friday, June 23, 2023
EASL, Therapy, TGF, DSMB, PBC, Pharmacokinetics, PET, Data monitoring committee, Fibrosis, Primary biliary cholangitis, Patient, Injury, SAN, Integrin, European Association for the Study of the Liver, PSC, Idiopathic pulmonary fibrosis, Primary sclerosing cholangitis, Safety, Pharmaceutical industry, Liver

“PSC is a rare chronic autoimmune disease with no effective therapy, representing a large unmet need for new treatments.

Key Points: 
  • “PSC is a rare chronic autoimmune disease with no effective therapy, representing a large unmet need for new treatments.
  • Our presentations this week discuss the early non-clinical work that support our ongoing Phase 2a clinical program.
  • We look forward to sharing interim data from this trial in the third quarter,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics.
  • The effects of bexotegrast on individual cell populations were evaluated in fibrotic PSC and primary biliary cholangitis (PBC) precision-cut liver slices.

Intercept Presents New Data Showing Significant Impact of OCA-bezafibrate Combination on Normalization of Multiple Biomarkers of PBC-Induced Liver Damage

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Friday, June 23, 2023
Intercept, FXR, EASL, Research and development, Bezafibrate, Therapy, Ursodeoxycholic acid, Hepatology, Serum, PBC, Cholestasis, Alanine transaminase, Safety, Cholesterol, GGT, Aes, ALP, University Hospitals Cleveland Medical Center, PPAR, Biomarker, Inflammation, Alkaline phosphatase, Congress, Development, Primary biliary cholangitis, Patient, Intercept Pharmaceuticals, Risk, OCA, UDCA, ALT, European Association for the Study of the Liver, FDA, AST, Death, Pharmaceutical industry, Vaccine, Liver, B200

MORRISTOWN, N.J., June 23, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced new results from a planned interim analysis of its ongoing Phase 2 study 747-213 assessing improvements in serum biomarkers of hepatic function, cholestasis and inflammation in patients with primary biliary cholangitis (PBC) after treatment with an investigational combination of obeticholic acid (OCA) and bezafibrate. Results from the full interim data set, shared in a podium presentation today at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria, showed that the combination of OCA 5-10 mg and bezafibrate 400 mg was effective in normalizing multiple biochemical markers associated with PBC-induced liver damage.

Key Points: 
  • “We have an opportunity to build on the improved transplant-free survival seen in patients with PBC taking OCA across multiple real-world studies.
  • The lower target for total bilirubin was selected as it is associated with the lowest risk for liver transplant or death.
  • Intercept expects to complete planned interim analyses from both ongoing Phase 2 studies this year.
  • Analyses from these Phase 2 studies, in addition to Phase 1 and preclinical data, will serve as the basis of an end-of-phase 2 meeting with FDA.

Sagimet Biosciences Presents Positive Phase 2b FASCINATE-2 Clinical Trial Interim Data for Denifanstat for the Treatment of NASH at EASL Congress 2023

Retrieved on: 
Friday, June 23, 2023
F3, EASL, University, Therapy, NASH, F2, FGF21, Biomarker, Inflammation, AASLD, University of California, San Diego, Non-alcoholic fatty liver disease, Congress, Fibrosis, Patient, Hepatology, SAN, LDL, FASN, Fatty liver disease, NAFLD, European Association for the Study of the Liver, Pharmaceutical industry, Liver

SAN MATEO, Calif., June 23, 2023 (GLOBE NEWSWIRE) --  Sagimet Biosciences Inc., a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today announced an oral presentation of data from the planned interim analysis of a prespecified subset of patients at week 26 of the Phase 2b FASCINATE-2 clinical trial of denifanstat, an investigational fatty acid synthase (FASN) inhibitor, in nonalcoholic steatohepatitis (NASH) patients with moderate to advanced fibrosis, stages F2 or F3, as confirmed by liver biopsy. These results were presented at the European Association for the Study of the Liver (EASL) Congress being held in Vienna from June 21-24, 2023, and were previously presented at The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2022.

Key Points: 
  • We are excited by the observed improvement across biomarkers, including a statistically significant 12.4 mg/dL reduction in LDL cholesterol and an increase in endogenous FGF21 by 73.1%.
  • FGF21 is a hormone that regulates important metabolic pathways, in particular insulin sensitivity, and has been known to decrease hepatocyte injury while suppressing inflammation and fibrosis.
  • At week 26, denifanstat-treated patients had an observable change in circulating blood lipid composition with a decrease in the di-/triglycerides that are unregulated in NASH and an increase in cardioprotective polyunsaturated di-/triglycerides.
  • These denifanstat-driven improvements are consistent with the Phase 2a FASCINATE-1 findings.”

Hepcludex® (Bulevirtide) Demonstrates Sustained Efficacy and Safety Profile in People With Chronic Hepatitis Delta Virus at 96 Weeks

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Friday, June 23, 2023
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Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S.

Key Points: 
  • Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S.
  • Study participants receiving either 2 mg or 10 mg bulevirtide achieved similar combined responses (ALT normalization and virological response) at Week 96.
  • The safety profile at Week 96 is consistent with what was observed at Week 48, with no resistance observed and no serious adverse events attributed to bulevirtide treatment.
  • In these regions, health authorities have not established the safety and efficacy of bulevirtide.

Asher Bio Presents New Preclinical Data Further Supporting Development of AB359 for Chronic Hepatitis B Virus at EASL International Liver Conference 2023

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Thursday, June 22, 2023
Oncology, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, DNA, EASL, Partnership, Drug development, Hepatitis B virus, Cancer, Infection, Immunotherapy, CD8, Patient, Annual general meeting, Viral, European Association for the Study of the Liver, HBV, Autoimmunity, Vaccine, Pharmaceutical industry, University, Liver

Asher Biotherapeutics , a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced new preclinical data supporting continued development of AB359, Asher Bio’s novel immunotherapy approach for chronic HBV.

Key Points: 
  • Asher Biotherapeutics , a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced new preclinical data supporting continued development of AB359, Asher Bio’s novel immunotherapy approach for chronic HBV.
  • AB359 is an investigational therapy designed to selectively activate CD8+ effector T cells, thereby offering the potential to enhance the immune response to chronic viral infections, including HBV.
  • The data will be presented in an oral presentation at the International Liver Congress™, the Annual Meeting of the European Association for the Study of the Liver (EASL) taking place in Vienna, Austria June 22-26, 2023.
  • The presentation will be available in the “Presentations and Posters” section of Asher Bio’s website: https://asherbio.com/pipeline/presentations-publications/ .

Precision BioSciences Announces Oral Presentation of Positive ARCUS® Gene Editing Data at International Liver Congress 2023

Retrieved on: 
Thursday, June 22, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, DNA, EASL, Serum, Gene editing, Inflammation, AAV, Messenger, Hepatocyte, Precision BioSciences, Liver cancer, Congress, Conditional sentence, CAR, Patient, Risk, Blood, Entrepreneurship, European Association for the Study of the Liver, Hepatitis B virus, CccDNA, Abstract, Death, Cirrhosis, HBV, Hepatitis, Genome, Vaccine, Liver, HBsAg

Hepatitis B virus (HBV) causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis.

Key Points: 
  • Hepatitis B virus (HBV) causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis.
  • There is no cure for chronic hepatitis B and current treatments rarely result in functional cure, primarily due to persistence of viral DNA in the liver.
  • This integrated HBV DNA produces the viral protein, hepatitis B surface antigen (HBsAg), which is secreted in the blood.
  • Eliminating both the cccDNA and HBsAg are key parameters for achieving a functional cure of HBV,” said Jeff Smith, Co-Founder and Chief Research Officer at Precision Biosciences.

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

Retrieved on: 
Thursday, June 22, 2023
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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

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Wednesday, June 21, 2023
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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
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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.