Portal Hypertension

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Galectin Therapeutics (GALT) Update / Briefing Transcript
2025-06-16 17:00
Summary of Galectin Therapeutics (GALT) Update / Briefing Company Overview - **Company**: Galectin Therapeutics (GALT) - **Focus**: Development of belapectin as a treatment for NASH cirrhosis and portal hypertension, addressing a significant unmet medical need [2][4] Industry Context - **Condition**: NASH cirrhosis is a leading cause of liver transplantation in the US, with an estimated 5 million adults affected, including 3.3 million with portal hypertension [8][9] - **Market Opportunity**: Belapectin is positioned as a first-in-class therapy for NASH cirrhosis, with peak sales potential estimated at $18 billion [15] Clinical Trial Insights - **Clinical Trials**: Multiple Phase IIb trials conducted, including the NAVIGATE trial, which focused on patients with NASH cirrhosis and portal hypertension [5][19] - **Mechanism of Action**: Belapectin is a Galectin-3 inhibitor, which has shown anti-inflammatory and anti-fibrotic effects in preclinical studies [5][6] NAVIGATE Trial Findings - **Patient Population**: Included patients with compensated NASH cirrhosis and portal hypertension, with no baseline varices [20][21] - **Primary Endpoint**: Focused on the development of esophageal varices and other hepatic decompensation events [22][36] - **Results**: - Statistically significant reduction in new varices in the belapectin 2 mg/kg group (11.3% vs. 22.3% in placebo) [27] - Reduction in liver stiffness observed, indicating less disease progression [28][30] - Safety profile comparable to placebo, with no significant adverse events reported [31][37] Key Opinion Leaders' Perspectives - **Expert Opinions**: KOLs emphasized the urgent need for effective therapies in the NASH cirrhosis population, highlighting belapectin's potential to fill this gap [8][9][12] - **Market Feedback**: Positive responses from payers and physicians regarding the clinical and economic benefits of belapectin [14] Additional Insights - **Endoscopic Endpoint**: The NAVIGATE trial utilized centrally adjudicated endoscopy videos to track variceal development, enhancing the reliability of results [39][41] - **Comparison with Other Therapies**: Belapectin targets a more advanced patient population compared to other investigational therapies, which often select for less severe cases [62][63] Conclusion - **Future Outlook**: Belapectin shows promise in addressing the unmet needs of patients with advanced NASH cirrhosis and portal hypertension, with a favorable safety profile and significant market potential [36][60]
Galectin Therapeutics to Host Virtual KOL Event to Discuss Belapectin for Treatment of MASH Cirrhosis and Portal Hypertension
Globenewswire· 2025-06-10 12:56
NORCROSS, Ga., June 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced that it will host a virtual key opinion leader (KOL) event on Monday, June 16, 2025 at 12:00 PM ET. To register, click here. The event will focus on the unmet need and current treatment landscape for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertens ...
Galectin Therapeutics Reports Financial Results for the Quarter Ended March 31, 2025 and Provides Business Update
Globenewswire· 2025-05-15 12:00
NORCROSS, Ga., May 15, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated "This quarter, we remained laser-focused on advancing additional analyses for belapectin. I was extremely encouraged by the feedback we received last week at the ...
Madrigal Pharmaceuticals (MDGL) Update / Briefing Transcript
2025-05-13 13:00
Madrigal Pharmaceuticals (MDGL) Update / Briefing May 13, 2025 08:00 AM ET Speaker0 Good day. Thank you for standing by. Welcome to Montreal Pharmaceuticals' Residra Two Year Compensated Mascidrosis Data and EASL twenty twenty five Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relat ...
Inventiva announces the publication in Biomedicine & Pharmacotherapy of the results from a preclinical study showing improvement of portal hypertension with lanifibranor treatment
GlobeNewswire News Room· 2025-02-26 21:00
Core Viewpoint - Inventiva announced the publication of preclinical study results indicating that lanifibranor may reduce Portal Hypertension (PH), a significant complication of chronic liver diseases, including MASH and cirrhosis [1][5][6]. Group 1: Study Overview - The study was a collaboration with Ghent University Hospital and evaluated lanifibranor's effects on PH independent of hepatic conditions [2]. - Two distinct mouse models were used: Partial Portal Vein Ligation (PPVL) and common Bile Duct Ligation (cBDL) [3]. Group 2: Results from PPVL Model - In the PPVL model, lanifibranor reduced portal pressure by 28% at 10 mg/kg (p=0.03) and 39% at 30 mg/kg (p=0.001) in a dose-dependent manner [3]. - Improvements were linked to vascular changes in the splanchnic compartment, including reduced blood flow in the superior mesenteric artery (p=0.07) and decreased endothelial cell staining [3]. Group 3: Results from cBDL Model - In the cBDL model, lanifibranor also reduced portal pressure and spleen weight while improving fibrosis [4]. - The treatment decreased dysfunction in Liver Sinusoidal Endothelial Cells (LSEC) and hepatic angiogenesis associated with fibrotic PH [4]. Group 4: Implications for Treatment - The study suggests that lanifibranor could be a therapeutic option for patients with clinically significant PH, addressing both intra-hepatic and extra-hepatic conditions [5][6]. - Prof. Sven Francque highlighted the potential of lanifibranor in managing complications related to portal hypertension in chronic liver diseases [6]. Group 5: About Lanifibranor - Lanifibranor is an orally available small molecule that activates all three PPAR isoforms, designed to induce anti-fibrotic, anti-inflammatory, and beneficial vascular changes [8]. - It is the only pan-PPAR agonist in clinical development for MASH, with Breakthrough Therapy and Fast Track designations from the FDA [8]. Group 6: About Inventiva - Inventiva is focused on developing oral small molecule therapies for MASH and other diseases with significant unmet medical needs [9]. - The company is currently evaluating lanifibranor in the NATiV3 pivotal Phase 3 clinical trial for MASH treatment [9].