Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin Inhibitor (GR-MD-02) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

The purpose of this study is to test the safety & efficacy of combination drugs versus placebo to treat metastatic melanoma and head and neck squamous cell carcinoma.

Start Date01 Jul 2023

Sponsor / Collaborator

Providence Health & Services

[+1]

NCT04365868

/ Active, not recruitingPhase 2/3

A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis

This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

Start Date22 Jun 2020

Sponsor / Collaborator

Galectin Therapeutics, Inc.

NCT04332432

/ CompletedPhase 1

A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment

This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects.

Start Date16 Jun 2020

Sponsor / Collaborator

Galectin Therapeutics, Inc.

100 Clinical Results associated with Belapectin

100 Translational Medicine associated with Belapectin

100 Patents (Medical) associated with Belapectin

Literatures (Medical) associated with Belapectin

31 Jul 2024·Journal of Clinical and Translational Hepatology

Pipeline of New Drug Treatment for Non-alcoholic Fatty Liver Disease/Metabolic Dysfunction-associated Steatotic Liver Disease

Review

Author: Hu, Ye ; Fan, Jian-Gao ; Liu, Yu-Dong ; Sun, Chao ; Chen, Ying

Given the global prevalence and rising incidence of metabolic dysfunction-associated steatotic liver disease (MASLD), the absence of licensed medications is striking. A deeper understanding of the heterogeneous nature of MASLD has recently contributed to the discovery of novel groups of agents and the potential repurposing of currently available medications. MASLD therapies center on four major pathways. Considering the close relationship between MASLD and type 2 diabetes, the first approach involves antidiabetic medications, including incretins, thiazolidinedione insulin sensitizers, and sodium-glucose cotransporter 2 inhibitors. The second approach targets hepatic lipid accumulation and the resultant metabolic stress. Agents in this group include peroxisome proliferator-activated receptor agonists (e.g., pioglitazone, elafibranor, saroglitazar), bile acid-farnesoid X receptor axis regulators (obeticholic acid), de novo lipogenesis inhibitors (aramchol, NDI-010976), and fibroblast growth factor 21/19 analogs. The third approach focuses on targeting oxidative stress, inflammation, and fibrosis. Agents in this group include antioxidants (vitamin E), tumor necrosis factor α pathway regulators (emricasan, pentoxifylline, ZSP1601), and immune modulators (cenicriviroc, belapectin). The final group targets the gut (IMM-124e, solithromycin). Combination therapies targeting different pathogenetic pathways may provide an alternative to MASLD treatment with higher efficacy and fewer side effects. This review aimed to provide an update on these medications.

01 Feb 2023·Alimentary pharmacology & therapeutics

Machine learning liver histology scores correlate with portal hypertension assessments in nonalcoholic steatohepatitis cirrhosis

Article

Author: Shlevin, Harold ; Harrison, Stephen A. ; Boudes, Pol ; Chalasani, Naga P. ; Ren, Yayun ; Tai, Dean ; Garcia‐Tsao, Guadalupe ; Chng, Elaine L. K. ; Noureddin, Mazen ; Goodman, Zachary

Summary:

Background and Aims:

In cirrhotic nonalcoholic steatohepatitis (NASH) clinical trials, primary efficacy endpoints have been hepatic venous pressure gradient (HVPG), liver histology and clinical liver outcomes. Important histologic features, such as septa thickness, nodules features and fibrosis area have not been included in the histologic assessment and may have important clinical relevance. We assessed these features with a machine learning (ML) model.

Methods:

NASH patients with compensated cirrhosis and HVPG ≥6 mm Hg (n = 143) from the Belapectin phase 2b trial were studied. Liver biopsies, HVPG measurements and upper endoscopies were performed at baseline and at end of treatment (EOT). A second harmonic generation/two‐photon excitation fluorescence provided an automated quantitative assessment of septa, nodules and fibrosis (SNOF). We created ML scores and tested their association with HVPG, clinically significant HVPG (≥10 mm Hg) and the presence of varices (SNOF‐V).

Results:

We derived 448 histologic variables (243 related to septa, 21 related to nodules and 184 related to fibrosis). The SNOF score (≥11.78) reliably distinguished CSPH at baseline and in the validation cohort (baseline + EOT) [AUC = 0.85 and 0.74, respectively]. The SNOF‐V score (≥0.57) distinguished the presence of varices at baseline and in the same validation cohort [AUC = 0.86 and 0.73, respectively]. Finally, the SNOF‐C score differentiated those who had >20% change in HVPG against those who did not, with an AUROC of 0.89.

Conclusion:

The ML algorithm accurately predicted HVPG, CSPH, the development of varices and HVPG changes in patients with NASH cirrhosis. The use of ML histology model in NASH cirrhosis trials may improve the assessment of key outcome changes.

01 Jan 2023·European journal of gastroenterology & hepatology

Pharmacotherapeutic efficacy on noninvasive fibrosis progression in nonalcoholic fatty liver disease: a systematic review and network meta-analysis

Review

Author: Gozar, Martin ; Da, Ben L. ; Bernstein, David ; Kovalic, Alexander J. ; Satapathy, Sanjaya K.

Background:

Fibrosis impacts long-term outcomes among patients with nonalcoholic fatty liver disease (NAFLD). Due to well-documented flaws associated with liver biopsy, there has been a recent emphasis on prioritizing noninvasive testing over liver biopsy for the assessment of fibrosis.

Methods:

A comprehensive systematic review and frequentist random effects network meta-analysis was performed among randomized controlled trials reporting pharmacologic intervention in NAFLD. The primary endpoint was the absolute change in liver stiffness measurement (LSM) via elastography. Secondary endpoints included changes in noninvasive serologic tests including APRI, fibrosis-4 index, NAFLD fibrosis score, enhanced liver fibrosis (ELF) and FibroTest (FibroSure in the USA).

Results:

Forty-five randomized controlled trials enrolling 6932 patients were identified for this network meta-analysis. Across the primary endpoint, firsocostat, semaglutide, montelukast, cilofexor plus firsocostat, obeticholic acid and diacerein (change in LSM via vibration controlled transient elastography), in addition to lubiprostone and pemafibrate (change in LSM via magnetic resonance elastography) were found to be the most effective and statistically significant treatment interventions. Similarly, the following interventions were determined to be most effective as compared to placebo among secondary endpoints: saroglitazar, lubiprostone, and obeticholic acid (change in APRI); saroglitazar, semaglutide, firsocostat and cilofexor plus firsocostat (change in ELF); obeticholic acid and belapectin [change in FibroTest/FibroSure].

Conclusion:

This is the first systematic review and network meta-analysis reporting pharmacologic efficacy in the progression of fibrosis based on noninvasive testing among patients with NAFLD. Semaglutide, obeticholic acid, firsocostat, cilofexor plus firsocostat and lubiprostone were found to be the most effective treatments based on their consistent efficacy reproduced across multiple endpoints, both via elastography and noninvasive blood tests.

News (Medical) associated with Belapectin

30 Jan 2025

·www.prnewswire.com

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NAFLD companies, including BeiGene, Inventiva Pharma, Cirius Therapeutics, Madrigal Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr. Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, Poxel SA, AngioLab, Pfizer, Oramed Pharmaceuticals, Can Fite Biopharma, MediciNova, Metacrine, Inc., Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Enanta Pharmaceuticals, Cascade Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

20 Dec 2024

·www.fiercebiotech.com

Galectin\'s MASH treatment reduces varices but fails to hit statistical significance in phase 3 trial

Since Galectin Therapeutics shared phase 3 data this morning, its stock has dropped 54% from $2 per share to 92 cents.\n Galectin Therapeutics’ stock has halved since the company revealed its investigational drug failed to significantly reduce enlarged veins for people with liver scarring.Since the biotech shared the phase 3 data this morning, the company’s stock has dropped 54%, from $2 per share to 92 cents.The data center around belapectin, a new chemical entity designed to target extracellular galectins, which are carbohydrate-binding proteins involved in many bodily functions. Galectin tested the candidate out in a late-stage trial, dubbed NAVIGATE, that enrolled 355 patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.Patients were randomized to one of three groups: In one arm, individuals received 2 mg of belapectin for each kilogram of lean body mass; another cohort of patients received 4 mg belapectin per kilogram; and the last arm received placebo. All received their assigned treatment every other week for 18 months.The trial’s primary endpoint was preventing varices, which are swollen veins in the esophagus. Galectin measured the endpoint as a combined clinical outcome that included patients with any varices, those with intercurrent events, or patients without an endoscopy or intercurrent events at 18 months. While Galectin found that esophageal varices incidence dropped for patients in both the 2-mg/kg and 4-mg/kg groups, the composite endpoint failed to hit statistical significance. “I am encouraged by the results demonstrating an approximately 49% reduction in the development of varices in patients with MASH cirrhosis with the previously studied belapectin dose of 2 mg in such a large, global trial,” Naim Alkhouri, M.D., chief medical officer and director of the steatotic liver program at Arizona Liver Health, said in a Dec. 20 release. “I believe the results warrant further clinical development as belapectin could become a pivotal therapeutic option for these patients that currently do not have any treatment options.”Belapectin was overall well tolerated, with a similar rate of adverse events and serious adverse events across treatment and placebo groups, according to Galectin.“All enrolled subjects transitioned into a 36-month treatment period, with approximately 50 subjects completing the full 36 months to date,” Galectin Chief Medical Officer Khurram Jamil, M.D., said in the release. “We are still analyzing the extensive data from the trial and anticipate providing multiple clinical updates from the subjects completing 36-month therapy, as well as additional biomarker data in Q1 2025.”The company plans to speak with potential pharma partners and medical experts to figure out the next steps for the investigational drug, Galectin CEO Joel Lewis said in the release.

$Galectin\'s MASH treatment reduces varices but fails to hit statistical significance in phase 3 trial$

Clinical ResultPhase 3

20 Dec 2024

·endpts.com

Idorsia’s Tryvio deal delay; Galectin’s liver drug disappoints

Plus, news about Pyxis, Epitopea and Genevant: Idorsia’s deal for blood pressure drug hits snag: The Swiss company said negotiations with an unnamed party for global rights to Tryvio are unlikely to end this year. Idorsia is looking at strategies to stretch its cash reserves until the deal is signed. Last month, the drugmaker announced plans for 270 potential layoffs. Its share price was down almost 50% on Friday. Galectin’s liver drug fails late-stage test: The biotech’s belapectin did not significantly reduce the development of enlarged blood vessels in people with cirrhosis and portal hypertension due to metabolic dysfunction-associated steatohepatitis, or MASH, in the placebo-controlled Phase 2/3 NAVIGATE trial. Galectin said it is analyzing the data to determine next steps. Its share price $GALT plummeted 47% at market open Friday. Pyxis doubles down on lead cancer program: The Boston biotech is stopping development of its monoclonal antibody PYX-106 to focus its resources on an ADC candidate dubbed PYX-201. This Phase 1 asset achieved a 50% objective response rate and a 100% disease control rate in a handful of head and neck cancer patients in November. Epitopea, Genevant ink cancer therapy pact: Epitopea will use Genevant’s lipid nanoparticle technology to develop RNA-based immunotherapies targeting certain proprietary tumor-specific antigens. The Canadian biotech could get up to $123.5 million in upfront and milestone fees for each product it makes with Epitopea.

Phase 1ImmunotherapyClinical ResultADC

100 Deals associated with Belapectin

External Link

KEGG	Wiki	ATC	Drug Bank
D11495	-	-	DB15125

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Esophageal and Gastric Varices	Phase 3	United States	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Argentina	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Australia	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Belgium	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Canada	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Chile	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	France	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Germany	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Israel	Galectin Therapeutics, Inc.	22 Jun 2020
Esophageal and Gastric Varices	Phase 3	Mexico	Galectin Therapeutics, Inc.	22 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04365868 (NAVIGATE, Company_Website) Manual	Phase 2/3	Nonalcoholic Steatohepatitis	355	Belapectin 2mg/kg/LBM	ahmwexmjpv(vdrgtwtogg) = lmosolcbcc pkegluccvd (akqvsdhnzy ) Not Met View more	Negative	20 Dec 2024
				belapectin 4 mg/kg/LBM	-
NCT02575404 (Biospace) Manual	Phase 1	Metastatic melanoma \| Head and Neck Neoplasms	14	Belapectin+KEYTRUDA (Melanoma)	xnsrictprf(czuunxeddz) = The most frequent adverse event related to pembrolizumab, in six patients, was grade 1 (mild) pruritus (itching), a known and labeled side-effect of pembrolizumab cstwfdcwhp (isyfpwqrtt ) View more	Positive	09 Jul 2021
				Belapectin+KEYTRUDA (HNSCC)
NCT02462967 (NASH-CX, CTgov)	Phase 2	Nonalcoholic Steatohepatitis \| Hypertension, Portal	162	GR-MD-02 (2 mg/kg GR MD 02)	rqabjztzuk(csyhnxwhyx) = srjtnqpbeu axegwcgpql (ymbqqtcxvu, 4.018) View more	-	08 Oct 2020
				GR-MD-02 (8 mg/kg GR MD 02)	rqabjztzuk(csyhnxwhyx) = tllninvijp axegwcgpql (ymbqqtcxvu, 3.100) View more
NCT02421094 (NASH-FX, CTgov)	Phase 2	Nonalcoholic Steatohepatitis \| Fibrosis	30	Placebo	ehdeaojfpx(ofzlfpqbtm) = tgrsmbbmyk qcdoqricqy (ikxmfwifcr, wkcdcvlxac - ssdmpuwvbm) View more	-	28 Sep 2020
NCT02462967 (Pubmed \| Gastroenterology)	Phase 2	Nonalcoholic Steatohepatitis \| Fibrosis \| Hypertension, Portal	162	Belapectin 2 mg/kg	dvxjjjfrwx(ywoykqeavq) = wbgosfmqwn smqrbnueem (uojucqgjwt )	-	01 Apr 2020
				Belapectin 8 mg/kg	dvxjjjfrwx(ywoykqeavq) = mfaccqfntu smqrbnueem (uojucqgjwt )
NCT02117362 (PipelineReview) Manual	Phase 1	Melanoma	-	Pembrolizumab+GR-MD-02	cygvbqxbby(bzulleylec) = gzhkulfulm rtoakihvzc (aufdwqqgns )	Positive	13 Nov 2017

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