VIRGINIA COMMONWEALTH UNIVERSITY

Wegovy Shows Promise in Treating MASH, a Serious Liver Disease

22 days ago

• A landmark Phase 3 clinical trial led by VCU and King's College London researchers found semaglutide significantly reduces liver inflammation and scarring in patients with metabolic dysfunction-associated steatohepatitis (MASH). • Nearly 63% of patients receiving semaglutide experienced reduced liver inflammation without worsening scarring, compared to only 34% in the placebo group, offering hope for the 15 million Americans affected by MASH. • If approved for MASH treatment, semaglutide (the compound in Wegovy and Ozempic) would provide a much-needed therapeutic option for a disease that currently has only one FDA-approved treatment and is a leading cause of liver transplants.

Federal Judge Orders CDC and FDA to Restore Public Health Websites Removed Under Trump Administration

a month ago

• U.S. District Judge John Bates has ordered the CDC and FDA to restore public health websites that were removed following Trump administration executive orders on gender, ruling the agencies likely violated federal law. • The removed resources included critical information on HIV prevention, youth health risks, fertility treatments, and the Social Vulnerability Index, impacting healthcare providers' ability to deliver evidence-based care. • Doctors for America successfully argued that the website removals would harm "everyday Americans, and most acutely, underprivileged Americans, seeking healthcare" for potentially life-threatening conditions.

Galmed's Aramchol Shows Promising Results in Enhancing Regorafenib's Efficacy Against GI Cancers

a month ago

• Aramchol, Galmed Pharmaceuticals' SCD1 inhibitor, significantly enhanced the anti-tumor effects of Bayer's Regorafenib in liver and colorectal cancer models through increased autophagy and death receptor signaling. • The drug combination demonstrated significant reduction in hepatic tumor growth in mice models without normal tissue toxicities, potentially offering a cost-effective alternative to current treatments for GI cancers. • A Phase 1b clinical trial evaluating the Aramchol-Regorafenib combination in patients with advanced GI cancers is planned to begin at Virginia Commonwealth University's Massey Cancer Center in Q4 2025.

Biotronik's Solia CSP S Lead Under Evaluation for Enhanced Left Bundle Branch Area Pacing

4 months ago

• Biotronik has enrolled the first patient in the second arm of the BIO-CONDUCT study to evaluate the Solia CSP S pacing lead for left bundle branch area pacing (LBBAP). • The Solia CSP S lead features design enhancements like a fixed helix and optimized distal end, aiming to simplify LBBAP procedures and improve patient outcomes. • LBBAP is gaining traction as a more physiological pacing method compared to conventional techniques, potentially offering better outcomes for heart failure patients. • Several vendors, including Medtronic, Boston Scientific, and Abbott, are developing and receiving FDA clearances for LBBAP-related devices and systems.

AI-Assisted Digital Pathology Improves Fibrosis Assessment in MASH Clinical Trials

5 months ago

• A new study demonstrates that AI-assisted digital pathology enhances the reliability of liver fibrosis evaluation in MASH, addressing variability in fibrosis staging. • The study, involving HistoIndex and Merck & Co., showed improved inter-pathologist agreement on fibrosis staging, especially in early-stage fibrosis (F0-F2). • HistoIndex's stain-free digital pathology platform provided more consistent and accurate assessment of fibrosis severity across the disease spectrum. • The AI tool has the potential to streamline clinical trials and improve the precision and personalization of care for MASH patients.

Viltolarsen Shows Positive Impact on Respiratory and Motor Function in DMD Patients

6 months ago

• Analysis of the Phase 2 Galactic53 trial indicates that viltolarsen provides respiratory and motor function benefits for DMD patients amenable to exon 53 skipping. • Viltolarsen-treated patients showed higher percent predicted forced vital capacity (FVC%p) at week 49 compared to controls, in both ambulatory and nonambulatory subgroups. • The study, although limited by small sample size and lack of placebo control, suggests potential benefits of viltolarsen in stabilizing or improving pulmonary function in DMD. • Viltolarsen was approved in 2020 under accelerated approval; Phase 3 trial results were mixed, further analyses are ongoing to determine clinical benefits.

Semaglutide 2.4 mg Shows Promise in MASH Treatment: Phase 3 ESSENCE Trial Results

6 months ago

• Semaglutide 2.4 mg demonstrated statistically significant improvements in liver fibrosis and resolution of steatohepatitis in MASH patients compared to placebo. • The ESSENCE trial met its primary endpoints, showing semaglutide's potential to slow MASH progression and reverse existing liver damage. • Secondary endpoints revealed improvements in liver enzymes (ALT, AST, GGT) and the Enhanced Liver Fibrosis (ELF) test with semaglutide treatment. • Novo Nordisk plans to file for regulatory approvals in the US in the first half of 2025, marking a step towards a new treatment option.

GENFIT to Initiate New ACLF Clinical Trials and Awaits Key Data Readouts in 2025

6 months ago

• GENFIT plans to launch two new clinical trials in Q1 2025 focusing on Acute-on-Chronic Liver Failure (ACLF) with VS-01 and a new formulation of NTZ. • The trials will include patients with acute decompensation at high risk of progressing to ACLF, aiming to streamline trial execution and patient recruitment. • GENFIT anticipates data readouts from four clinical trials by the end of 2025, including the UNVEIL-IT Phase 2 trial and a Phase 1b trial for GNS561 in cholangiocarcinoma. • Strategic insights from real-world evidence and collaborations with experts have informed the trial designs, broadening inclusion criteria to address the ACLF continuum.

Survodutide Receives FDA Breakthrough Therapy Designation for MASH, Phase III Trials Begin

7 months ago

• The FDA has granted Breakthrough Therapy designation to Boehringer Ingelheim's survodutide for adults with non-cirrhotic MASH and moderate to advanced fibrosis. • Survodutide's designation is based on clinical data demonstrating potential improvement over existing therapies for MASH and advanced fibrosis. • Boehringer Ingelheim has initiated two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, to evaluate the efficacy and safety of survodutide in MASH patients. • Survodutide is a dual glucagon/GLP-1 receptor agonist, offering a novel approach to address the unmet medical need in MASH treatment.

Hypofractionated Radiotherapy Shows Non-Inferior Lymphedema Risk in Early Breast Cancer

8 months ago

• A phase 3 trial (HypoG-01) demonstrated that moderately hypofractionated locoregional radiation therapy is non-inferior to standard normofractionated radiation therapy for early breast cancer patients. • The 5-year cumulative incidence of arm lymphedema was comparable between the hypofractionated (33.3%) and normofractionated (32.8%) radiotherapy arms. • Hypofractionated radiotherapy did not show detrimental effects on survival outcomes, local recurrence-free survival, or distant disease-free survival. • The findings suggest a shift towards a 3-week hypofractionated regimen, even for nodal radiotherapy, potentially reducing treatment burden and healthcare costs.

Sequana Medical to Present alfapump® Safety and Quality of Life Data at EASL Congress 2024

a year ago

Sequana Medical announces significant findings from its North American pivotal POSEIDON study on the alfapump® system, highlighting improved quality of life for patients with recurrent or refractory ascites due to liver cirrhosis. The data, to be presented at the EASL Congress 2024, shows the alfapump's safety profile is comparable to standard care, with a strong preference among US patients for the device over traditional paracentesis procedures.