Fibrosis

Bridge Biotherapeutics Launches a Research Collaboration with Emory University School of Medicine to Explore Combination Therapy of BBT-877 for KRAS/P53 Mutant NSCLC Patients Resistant to Anti-PD-1 Blockade

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Thursday, March 28, 2024
Emory University, CD4, CD8, Immunotherapy, Lab, Oncology, Inflammation, Patient, Immunosuppression, Neoplasm, Research, ATX, Cancer, Lung cancer, Winship Cancer Institute, Fibrosis, Hematology, Pharmaceutical industry

As a member of the cancer immunology research program at Winship Cancer Institute of Emory University, Dr. Konen's research has shown that autotaxin has a direct impact on the body's immune response to tumors.

Key Points: 
  • As a member of the cancer immunology research program at Winship Cancer Institute of Emory University, Dr. Konen's research has shown that autotaxin has a direct impact on the body's immune response to tumors.
  • The ongoing research collaboration is dedicated to investigating the potential benefits of combining BBT-877 with anti-PD-1 therapy as a treatment approach.
  • "We are pleased to work with Bridge Biotherapeutics to explore indication expansion into NSCLC through a combination of BBT-877 with anti-PD-1 agent and potentially offer new hope to those patients."
  • Together, the two entities will conduct preclinical studies to evaluate the therapeutic potential of BBT-877 in enhancing anti-tumor immunity.

Bridge Biotherapeutics Announces a Research Collaboration with the University of Colorado School of Medicine to Explore Potential of BBT-877 for Immuno-Oncology

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Tuesday, March 26, 2024
LPA, Microbiology, Metabolism, CD8, LPAR, LPAR5, Lab, Inflammation, Research, Immunology, ATX, Cancer, University, Fibrosis, Schweizer SGU 1-6, Vaccine

The collaboration will focus on exploring the potential of BBT-877, a novel autotaxin (ATX) inhibitor, as an immuno-oncology treatment for cancer.

Key Points: 
  • The collaboration will focus on exploring the potential of BBT-877, a novel autotaxin (ATX) inhibitor, as an immuno-oncology treatment for cancer.
  • "We are excited to collaborate with Dr. Torres's Lab to investigate the potential of BBT-877 as a novel immuno-oncology treatment," said James Lee, CEO of Bridge Biotherapeutics.
  • Under the terms of the collaboration, Bridge Biotherapeutics will provide financial support and access to BBT-877, while Dr. Raul Torres's Lab will contribute its expertise in immunology and cancer biology.
  • Together, the two entities will conduct preclinical studies to evaluate the therapeutic potential of BBT-877 in enhancing anti-tumor immunity.

Galmed Announces Grant of New Patent for the Combination of Aramchol with Resmetirom (MGL-3196, REZDIFFRA) for the Treatment of NASH and Liver Fibrosis

Retrieved on: 
Friday, March 15, 2024
Cirrhosis, BID, Aramchol, SCD1, Fibrosis, Patent, NASH, Liver, TEL

With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until September 2039.

Key Points: 
  • With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until September 2039.
  • Previously, Galmed reported results from the Open-Label part of its Phase 3 NASH study, which demonstrated that treatment with Aramchol 300mg BID resulted in a high rate of subjects with fibrosis improvement.
  • Mr. Baharaff continued "It is clear today that NASH is a chronic condition with multiple liver pathologies.
  • By combining Aramchol and Resmetirom, two distinct and selective compounds with complementary mechanisms, we believe this will provide a perfect treatment for NASH."

American Liver Foundation Statement on FDA Approval of Resmetirom

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Thursday, March 14, 2024
HCC, Liver failure, American Liver Foundation, Fatty liver disease, Liver disease, Disease, Caregiver, Risk, Cirrhosis, Inflammation, Chairperson, Patient, Life, Liver transplantation, Hope, Doctor of Philosophy, MASH, MD, ALF, Pharmacotherapy, Fibrosis, NASH, Hepatology, Hepatocellular carcinoma, NAFLD, FDA, Liver, Food, Pharmaceutical industry

FAIRFIELD, N.J., March 14, 2024 /PRNewswire/ -- Today, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis. NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease* (NAFLD) and causes inflammation in the liver and liver damage.

Key Points: 
  • NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease * (NAFLD) and causes inflammation in the liver and liver damage.
  • "American Liver Foundation applauds the FDA approval of the groundbreaking new drug therapy treatment, resmetirom, for patients with NASH who have progressed to fibrosis," said Lorraine Stiehl , Chief Executive Officer, American Liver Foundation.
  • American Liver Foundation offers many free resources to patients and families affected by liver disease.
  • *Note: The nomenclature for NAFLD and NASH recently changed to metabolic dysfunction-associated liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) respectively.

FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease

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Thursday, March 14, 2024
Research, Inflammation, Liver, Exercise, Disease, Drug, Dietary supplement, Patient, Fatty liver disease, Public, Animal, Immunology, Diarrhea, Marie Cassidy, Human services, Breakthrough therapy, Diet, Nausea, Priority review, Fibrosis, Heated tobacco product, Senior counsel, Safety, NASH, Hepatitis, Cosmetics, Vaccine, Food, Multimedia, Scar, FDA

NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction.

Key Points: 
  • NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction.
  • Rezdiffra is a partial activator of a thyroid hormone receptor; activation of this receptor by Rezdiffra in the liver reduces liver fat accumulation.
  • To enroll in the trial, patients needed to have a liver biopsy showing inflammation due to NASH with moderate or advanced liver scarring.
  • Patients should stop using Rezdiffra if they develop signs or symptoms of worsening liver function while on Rezdiffra treatment.

Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Cohort D Study in Clinical Gastroenterology and Hepatology

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Thursday, March 7, 2024
SAN, EFX, T2D, Diarrhea, Liver injury, Obesity, ALT, Nausea, ELF, DSM-IV codes, Type 2 diabetes, Safety, MASH, Diabetes, Histology, Therapy, Lipid metabolism, Patient, Fibrosis, NASH, Appetite, Hepatology, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study.
  • Tolerability of EFX on top of GLP-1RA (N=21 patients) was generally comparable to GLP-1RA alone (placebo, N=10).
  • The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite).
  • Patients treated with EFX plus GLP-1RA showed a similar mean weight loss from baseline relative to patients treated with GLP-1RA alone.

Madrigal Pharmaceuticals Announces EMA Validation of its Marketing Authorization Application for Resmetirom for the Treatment of NASH/MASH with Liver Fibrosis

Retrieved on: 
Tuesday, March 5, 2024
Therapy, EMA, Committee, MAA, FDA, PDUFA, Liver cancer, Cirrhosis, Liver failure, Data, THR, MASH, Chronic, CHMP, Death, Patient, Fibrosis, NASH, Disease, Breakthrough therapy, Fatty liver disease, Development, Priority review, Pharmaceutical industry

NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.

Key Points: 
  • NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.
  • Resmetirom is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH.
  • The clinical development program for resmetirom is comprised of 18 clinical studies supporting the MAA: twelve Phase 1 studies, two Phase 2 studies, and four Phase 3 studies.
  • Without treatment, the disease can lead to cirrhosis, liver failure, liver cancer and premature death,” said Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal.

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Retrieved on: 
Tuesday, March 5, 2024
CNRS, Regeneration, Crohn's disease, EIC, Exosome, Quality of life, Fistula, Stenosis, B cell, Patient, Fibrosis, Intellectual property, Congress, Research, ECCO, Pharmaceutical industry

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Key Points: 
  • Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.
  • This new worldwide license marks a significant step forward in EVerZom's mission to bring innovative exosome-based therapeutic solutions to patients suffering from serious digestive diseases.
  • Paris, March 5, 2024 - EVerZom, a CNRS/Université Paris Cité spin-off specializing in exosomes, has announced the signature of a second exclusive license agreement with Erganeo for the development of EVerGel ™, a drug candidate tailored for the healing of digestive tissues.
  • EVerZom's first clinical application focuses on digestive tissue regeneration using naive exosomes derived from stem cells encapsulated in a gel called EVerGel ™.

Akero Therapeutics Reports Statistically Significant Histological Improvements at Week 96 in Phase 2b HARMONY Study

Retrieved on: 
Monday, March 4, 2024
Fibrosis, F3, Cirrhosis, EFX, Marie Cassidy, MASH, Biopsy, Patient, Risk, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 04, 2024 (GLOBE NEWSWIRE) --  Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today released preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3). The study previously met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups, compared to 20% for the placebo arm. At week 96, the response rates on this endpoint increased to 75% (p

Key Points: 
  • Specifically, the placebo-adjusted effect sizes for fibrosis improvement without worsening of MASH grew from 21% to 52% between week 24 and week 96 for 50mg EFX and from 20% to 22% for 28mg EFX.
  • Highly statistically significant results for 50mg EFX at week 96 are notable because (1) the study was not fully powered at week 96 and (2) the placebo rate increased rather than decreased.
  • Analysis of the evolution of responses between weeks 24 and 96 indicated not only broader fibrosis improvement without worsening of MASH but also sustained response, particularly at 50mg EFX.
  • Among those patients with available week 96 biopsies whose fibrosis improved at week 24, 92% and 83% of the 50mg and 28mg EFX groups remained responders, respectively, compared to 40% for placebo.

89bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Thursday, February 29, 2024
Liver, SAN, FGF21, EMA, Research, AASLD, FDA, Research and development, Cirrhosis, Standard of care, Hepatitis, Safety, European Medicines Agency, Administration, Patient, Fibrosis, NASH, Pharmaceutical industry

SAN FRANCISCO, Feb. 29, 2024 (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 reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided corporate updates.

Key Points: 
  • ENLIGHTEN-Fibrosis is expected to enroll non-cirrhotic patients with fibrosis stage F2-F3 and ENLIGHTEN-Cirrhosis is expected to enroll NASH patients with compensated cirrhosis (F4).
  • ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis are expected to initiate in the first and second quarter of 2024, respectively.
  • Completed follow-on offering in the fourth quarter of 2023 for $172.5 million in gross proceeds.
  • The foregoing financial information is unaudited and subject to change, and actual results may vary from the foregoing.