EASL

1,000th alfapump® implant completed

Retrieved on: 
Thursday, July 6, 2023
Overload, EASL, Heart failure, Prevalence, Heart, Liver disease, Cancer, Quality of life, DSR, Patient, Brussels Stock Exchange, Ascites, Nashi, Cirrhosis, Medical imaging

The Company also reports that it has received all administrative clearances to start the US MOJAVE study of DSR 2.0 in congestive heart failure patients and expects to enroll the first patient imminently.

Key Points: 
  • The Company also reports that it has received all administrative clearances to start the US MOJAVE study of DSR 2.0 in congestive heart failure patients and expects to enroll the first patient imminently.
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “We developed the alfapump to transform the lives of patients with recurrent and refractory ascites due to liver disease.
  • A 63-year old alfapump patient from Canada said: “The alfapump changed my life.
  • I got lucky with the alfapump, my daily routine is getting back, with no pain and suffering, just feeling good

Arrowhead Presents Updated Data from Phase 2 SEQUOIA Study of Investigational RNAi Therapy Fazirsiran in Patients with Alpha-1 Antitrypsin Deficiency Liver Disease

Retrieved on: 
Saturday, June 24, 2023
Research, General Health, Pharmaceutical, Oncology, Infectious Diseases, Genetics, Clinical Trials, Science, Cardiology, Biotechnology, FDA, Health, SEQUOIA, Arrowhead, EASL, Liver disease, Serum, The New England Journal of Medicine, TAK, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Trial of the century, Congress, Arrowhead Pharmaceuticals, Patient, European Association for the Study of the Liver, F4, Pharmaceutical industry, Takeda, Liver

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented updated results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD).

Key Points: 
  • Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented updated results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD).
  • The SEQUOIA Phase 2 data are consistent with the promising results from an open-label Phase 2 trial of fazirsiran (AROAAT2002) that were published in The New England Journal of Medicine .
  • Takeda (TSE:4502/NYSE:TAK) and Arrowhead are further investigating fazirsiran in the ongoing pivotal Phase 3 REDWOOD clinical study which is actively recruiting a total of 160 patients.
  • Fazirsiran treatment demonstrated a substantial effect on several key markers of liver disease,” said Javier San Martin, M.D., chief medical officer at Arrowhead.

Data from 89bio’s ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH) Published in The New England Journal of Medicine and Simultaneously Presented in a Late-breaker Session at the EASL International Liver Congress

Retrieved on: 
Saturday, June 24, 2023
The New England Journal of Medicine, EASL, Nutrition, Histology, Tremor, University, FAST, NASH, Diarrhea, F2, NAS, Week, Vibration, Aes, Research, FGF21, Biomarker, Appetite, ELF, NEJM, Congress, Fibrosis, Clinical study design, Hepatitis, Vital signs, Patient, Metabolic syndrome, Nature, SAN, Division, Virginia Commonwealth University, Nausea, ALT, Fatty liver disease, DEXA, European Association for the Study of the Liver, FDA, Hepatology, Adiponectin, Cirrhosis, National Institutes of Technology (India), Safety, Biopsy, Pharmaceutical industry, Medical imaging, Liver, Gastroenterology, Glycated hemoglobin

SAN FRANCISCO, June 24, 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 cardio-metabolic diseases, today announced that data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH) were published online in the New England Journal of Medicine (NEJM). The data were simultaneously presented in a late-breaking oral session today at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria and were also selected for inclusion in the Best of EASL Congress summary.

Key Points: 
  • The published manuscript titled “A Randomized, Controlled Trial of the FGF21 Analog Pegozafermin in NASH” is available online.
  • A copy of the EASL oral presentation will be accessible under “Scientific Publications” in the pipeline section of 89bio’s website .
  • Treatment with pegozafermin also led to clinically meaningful changes compared to baseline in liver fat and other key non-invasive tests (NITs) of liver inflammation and fibrosis.
  • Five out of eleven of these patients treated with pegozafermin had fibrosis improvement ≥1 stage without worsening of NASH.

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

Retrieved on: 
Friday, June 23, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Chloride, ALGS, Maintenance, EASL, Hippeastrum mirum, Cholestasis, SBA, Sleep, Research, Doctor of Philosophy, MRX, Medication, Congress, HIV disease progression rates, Patient, Concentration ratio, Bilirubin, Itch, Progressive familial intrahepatic cholestasis, IBAT, Alagille syndrome, Ageing, European Association for the Study of the Liver, PFIC, Safety, Pharmaceutical industry, Medical imaging, Fertilizer, Surveying, Toy, Liver

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

Retrieved on: 
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

Retrieved on: 
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

Retrieved on: 
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.