A Double-Blind, Multicenter, Placebo-Controlled, Randomized, Parallel, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

The purpose of this study is to evaluate the safety, tolerability, and drug level of Pegbelfermin in healthy overweight and obese Chinese and Korean participants.

Start Date21 Jun 2021

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT04634149

/ CompletedPhase 1

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment

The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.

Start Date23 Nov 2020

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT04493567

/ CompletedPhase 1

An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.

Start Date29 Jul 2020

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Pegbelfermin(Ambrx, Inc.)

100 Translational Medicine associated with Pegbelfermin(Ambrx, Inc.)

100 Patents (Medical) associated with Pegbelfermin(Ambrx, Inc.)

Literatures (Medical) associated with Pegbelfermin(Ambrx, Inc.)

01 Mar 2025·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

FGF21 Signaling Exerts Antifibrotic Properties during Pulmonary Fibrosis

Article

Author: Jaillet, Madeleine ; Poté, Nicolas ; Cazes, Aurélie ; Archer, Gabrielle ; Vasarmidi, Eirini ; Mal, Hervé ; Ghanem, Mada ; Mailleux, Arnaud ; Mordant, Pierre ; Crestani, Bruno ; Justet, Aurélien ; Castier, Yves

Rationale: Idiopathic pulmonary fibrosis (IPF) is a lethal disease with limited therapeutic options. FGF21 (fibroblast growth factor 21), an endocrine fibroblast growth factor that acts through the FGFR1 (fibroblast growth factor receptor 1)/KLB (β-Klotho) pathway, mitigates liver fibrosis. Objectives: We hypothesized that FGF21 could exert antifibrotic properties in the lung. Methods: The concentrations of FGF21 and KLB in the plasma of patients with IPF and control subjects were assessed. Pulmonary fibrosis development was assessed in Fgf21-deficient mice compared with wild-type littermates, at Day 14 (D14) after the intratracheal injection of bleomycin. We determined the effect of repeated subcutaneous injections of a PEGylated FGF21 analog at D7, D10, D14, and D17 after bleomycin on the development of pulmonary fibrosis. Mice were killed at D21. The effects of FGF21, alone or with KLB, on apoptosis in murine lung epithelial 15 cells and on the phenotype of human lung fibroblasts were assessed in vitro. Measurements and Main Results: In the plasma of patients with IPF, FGF21 concentrations were increased, while KLB concentrations were decreased. Fgf21-deficient mice showed increased sensitivity to bleomycin in comparison with their wild-type littermates. Treatment with PEGylated FGF21 mitigated lung fibrogenesis, as evidenced by a lower injury score and decreased fibrosis markers and profibrotic mediator expression compared with the control group receiving the diluent. In murine lung epithelial 15 cells, stimulation with FGF21 and KLB inhibited apoptosis, through the decrease of BAX and BIM. Fibroblastic phenotype remained unaltered. Conclusions: Our data indicate a possible antifibrotic effect of FGF21 in the lung achieved through the inhibition of alveolar type 2 cell apoptosis.

01 Mar 2025·JGH Open

Evaluating the Effectiveness of Pegbelfermin in MASH‐Associated Hepatic Fibrosis A Meta‐Analysis and Systematic Review of Randomized Controlled Trials

Article

Author: Faisal, Muhammad Saad ; Gangwani, Manesh Kumar ; Chaudhary, Ammad Javaid ; Kazmi, Syeda Kanza ; Hasan, Fariha ; Shabbar, UmmeSalma ; Mohan, Babu P. ; Williams, Kathy N. ; Shahzil, Muhammad ; Khaqan, Muhammad Ali ; Tofani, Christina

ABSTRACT:

Introduction:

Metabolic dysfunction‐associated steatohepatitis (MASH), an advanced form of fatty liver disease, is characterized by liver inflammation and fibrosis, with an emerging interest in fibroblast growth factor (FGF)‐21 analogs, particularly pegbelfermin (PGBF). This study evaluates the efficacy and safety of PGBF in treating MASH‐associated hepatic fibrosis.

Methods:

This meta‐analysis followed Cochrane guidelines and PRISMA standards. A comprehensive search of databases up to January 2023 focused on randomized controlled trials (RCTs) comparing PGBF to placebo for MASH. Meta‐analyses were performed with RevMan 5.4 using a random‐effects model.

Results:

Data from 452 participants across three RCTs were analyzed. Significant improvements in adiponectin concentration were observed in both the 10 mg [MD = 18.23, 95% CI (6.35, 30.11), p = 0.003] and 20 mg [MD = 18.09, 95% CI (5.88, 30.31), p = 0.004] PGBF groups compared to placebo. Significant reductions in PRO‐C3 concentration were noted in both the 10 mg [MD = −25.50, 95% CI (−43.95, −7.05), p = 0.007] and 20 mg [MD = −19.54, 95% CI (−33.33, −5.76), p = 0.005] groups. Significant improvement in MASH was seen in the 10 mg group [RR = 2.84, 95% CI (1.18, 6.78), p = 0.02] but not in the 20 mg group. No significant improvements in liver stiffness, Modified Ishak scores, collagen proportionate area, ALT and AST levels, or treatment‐emergent adverse events (TEAEs) were observed in either dosage group.

Conclusions:

Pegbelfermin, a promising therapy for MASH fibrosis, has demonstrated effectiveness at 10 mg, significantly improving MASH and biomarkers including adiponectin and PRO‐C3, while maintaining a generally safe profile.

01 Jul 2024·Clinical pharmacology and therapeutics

Efficacy and Safety of Fibroblast Growth Factor‐21 Analogs for the Treatment of Metabolic Dysfunction‐Associated Steatohepatitis: A Systematic Review and Meta‐Analysis

Review

Author: Kim, Min‐Soo ; Jeon, Nakyung ; Rhee, Su‐jin ; Han, Nayoung ; Staatz, Christine E. ; Baek, In‐hwan ; Jeong, Changhyeon

Fibroblast growth factor (FGF)‐21 analogs are potential therapeutic candidates for metabolic dysfunction‐associated steatohepatitis (MASH). This systematic review and meta‐analysis aimed to assess the efficacy and safety of the FGF‐21 analogs, efruxifermin, pegbelfermin, and pegozafermin for MASH treatment. A comprehensive systematic review and meta‐analysis of randomized controlled trials from five major databases was conducted. Primary efficacy outcomes focused on liver histological improvement, while secondary efficacy outcomes encompassed reductions in liver fat content and improvements in biochemical parameters. Safety outcomes examined included treatment‐emergent adverse events (TEAEs), treatment‐related TEAEs, TEAEs leading to discontinuation, and serious TEAEs. Eight eligible studies involving 963 patients were included in this review. Compared with the placebo group, the FGF‐21 analog‐treated group exhibited significantly improved primary efficacy outcomes, specifically ≥1 stage improvement in fibrosis with no worsening of MASH (risk ratio [RR] = 1.83; 95% confidence interval [CI] = 1.27–2.62) and at least two‐point improvement in the non‐alcoholic fatty liver disease activity score with no worsening of fibrosis (RR = 2.85; 95% CI = 2.06–3.95). Despite an increased risk of TEAEs (RR = 1.17; 95% CI = 1.08–1.27) and treatment‐related adverse events (RR = 1.75; 95% CI = 1.40–2.19), FGF‐21 analogs exhibited an acceptable safety profile. FGF‐21 analogs were significantly better in achieving liver histological improvements and beneficial biochemical outcomes compared with placebo, with a tolerable safety pattern. These findings shed light on the efficacy and safety of FGF‐21 analogs and provide valuable evidence for their application as MASH therapeutics.

News (Medical) associated with Pegbelfermin(Ambrx, Inc.)

12 Dec 2022

·www.prnewswire.com

Propulsion of Nonalcoholic Steatohepatitis Pipeline as Novel and Extensive 150+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of nonalcoholic steatohepatitis has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Nonalcoholic Steatohepatitis and the growing research and development activities drive the market. The Companies developing the potential therapies in the last stage of development include Madrigal Pharmaceuticals, Inventiva, Boehringer Ingelheim, and several others. LAS VEGAS, Dec. 12, 2022 /PRNewswire/ -- DelveInsight's ' Nonalcoholic Steatohepatitis Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline nonalcoholic steatohepatitis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the nonalcoholic steatohepatitis pipeline domain. Key Takeaways from the Nonalcoholic Steatohepatitis Pipeline Report DelveInsight's nonalcoholic steatohepatitis pipeline report depicts a robust space with 130+ active players working to develop 150+ pipeline therapies for nonalcoholic steatohepatitis treatment. Key nonalcoholic steatohepatitis companies such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, 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, 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, and others are evaluating nonalcoholic steatohepatitis drugs to improve the treatment landscape. Promising nonalcoholic steatohepatitis pipeline therapies in various stages of development include TERN-101, SNP-610, LJN452 (tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. In November 2022, Sagimet Biosciences announced positive interim data from its Phase IIb clinical trial (FASCINATE-2) with denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis patients. Data showed statistically significant improvements across key markers of NASH, reinforcing results observed in earlier studies, including statistically significant reductions in markers of liver fat, inflammation, and fibrosis. There were no treatment-related serious adverse events, with the majority of adverse events mild to moderate in nature (Grade 1 and 2). Additional interim data are expected in early 2023. In November 2022, Inventiva announced that the United States Patent and Trademark Office granted a patent (U.S. Patent No. 11,504,380) that protects the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage. This patent will expire on November 8, 2039. This patent further expands the intellectual property protection of lanifibranor in the United States for use in patients with cirrhotic NASH. In October 2022, Galectin Therapeutics, Inc. reported the positive outcome of its second data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase IIb/III study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The objective of this second independent DSMB was further to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE could continue as designed, without modifications. In September 2022, Inventiva and Chia Tai-Tianqing Pharmaceutical Group entered into a licensing and collaboration agreement to develop and commercialize lanifibranor, if approved, for the treatment of nonalcoholic steatohepatitis and potentially other metabolic diseases in mainland China, Hong Kong, Macau, and Taiwan. In June 2022, Poxel SA announced that the U.S. Patent and Trademark Office (PTO) has issued to Poxel US Patent No. 11319313, which represents a new patent for PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which is being investigated in Phase II stage of clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis (NASH). In May 2022, Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). In May 2022, Hepion Pharmaceuticals, Inc. announced that it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for evaluating liver function and health in patients with chronic liver diseases. Hepion will incorporate the HepQuant 'SHUNT' test into a dedicated Phase IIb clinical trial in presumed NASH F3 subjects. In February 2022, the US Food and Drug Administration (FDA) granted a Fast-Track Designation to Axcella Therapeutics' AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. In January 2022, LISCure Biosciences announced that it had executed a research collaboration agreement with Mayo Clinic for new drug development for rare liver diseases. LISCure Biosciences Inc. has executed a research collaboration agreement with US based-Mayo Clinic for new drug development for rare liver diseases. Request a sample and discover the nash drugs in development 2022 @ Nonalcoholic Steatohepatitis Pipeline 2022 Report The nonalcoholic steatohepatitis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage nonalcoholic steatohepatitis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the nonalcoholic steatohepatitis clinical trial landscape. Nonalcoholic Steatohepatitis Overview Nonalcoholic steatohepatitis (NASH) is a type of liver inflammation and damage caused by fat buildup. It is one of several conditions known as nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease is classified into two types: isolated fatty liver, in which only fat accumulates, and nonalcoholic steatohepatitis, in which fat, inflammation, and liver cell damage occur. NASH does not usually cause symptoms. Most people with NASH feel fine and are unaware that they have it. As NASH progresses and liver damage worsens, a patient may experience fatigue, weight loss, general weakness, and acne in the upper right part of the belly. Screening for nonalcoholic fatty liver disease in the general population is not advised. It is usually considered after discovering unexplained liver enzyme levels, or imaging reveals hepatic steatosis. A patient's medical history, a physical exam, and tests for nonalcoholic steatohepatitis are used by doctors. Want to discover how the Nash treatment pipeline will look like? Request for sample @ NASH Drug Pipeline 2022 A snapshot of the Nonalcoholic Steatohepatitis Pipeline Drugs mentioned in the report: Want to know how nash dash the pipeline race is for new agents? Download the sample page @ NASH Clinical Trials Nonalcoholic Steatohepatitis Therapeutics Assessment The nonalcoholic steatohepatitis pipeline report proffers an integral view of nonalcoholic steatohepatitis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Nonalcoholic Steatohepatitis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Parenteral, Oral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Biologic, Cell therapy, Peptide, Protein, Small molecule Therapeutics Assessment By Mechanism of Action: Adiponutrin inhibitor, Diacylglycerol O acyltransferase inhibitor, Adiponutrin modulator, RNA interference, Glucagon like peptide 1 receptor agonist, Ornithine decarboxylase stimulant, Farnesoid X-activated receptor agonist, Thyroid hormone receptor beta agonist, Mitochondrial membrane transport protein modulator, Thyroid hormone receptor beta agonists, Peroxisome proliferator-activated receptor alpha agonist Key Nonalcoholic Steatohepatitis Companies:Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, 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, 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, and others. Key Nonalcoholic Steatohepatitis Pipeline Therapies: TERN-101, SNP-610, LJN452(tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. Dive deep into rich insights for nonalcoholic steatohepatitis research; visit @ NASH Treatment Pipeline Table of Contents For further information on the most promising nash drugs, reach out @ NASH Medication Pipeline Related Reports Nonalcoholic Steatohepatitis Epidemiology Nonalcoholic Steatohepatitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted nonalcoholic steatohepatitis epidemiology in the 7MM. Nonalcoholic Steatohepatitis Market Nonalcoholic Steatohepatitis Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key nonalcoholic steatohepatitis companies, including Boehringer Ingelheim, Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, Cirius Therapeutics, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non-alcoholic fatty liver disease companies including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced non-alcoholic fatty liver disease companies, including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Epidemiology Non-Alcoholic Fatty Liver Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted non-alcoholic fatty liver disease epidemiology in the 7MM. Other Trending Reports Alcohol Use Disorder Market | Liver Cancer Market | Alcoholic Hepatitis - Market | Acute Liver Failure - Market | Liver Angiosarcoma - Market | Liver Cirrhosis - Market | Chronic Liver Disease - Market | Advanced Liver Cancer - Market | Acute On Chronic Liver Failure (ACLF) Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research LLP

Phase 2License out/inFast Track

20 Jun 2022

·www.biospace.com

PharmaNest to Present Eight Digital Pathology and AI Abstracts at the International Liver Congress 2022PharmaNest

PRINCETON, N.J., June 20, 2022 (GLOBE NEWSWIRE) --Pharmanest, an emerging leader in quantitative Digital Pathology and Artificial Intelligence, announces today that it will be present, alongside with its collaborators, eight presentations at this year's International Liver Congress (ILC) in London, June 22-25, 2022. The abstracts highlight the utility and performance of FibroNest, the first multi-vendor quantitative digital Pathology image analysis and translational platform for the assessment of the severity and progression of Fibrosis and disease activity in NASH. "The automated quantification of the phenotype of fibrosis severity from the same slides reviewed by pathologists offers a robust and scalable method to generate continuous scores with a detection threshold that can detect faint changes and drug effects," said Mathieu Petitjean, CEO and founder of Pharmanest. Because the approach is fully quantitative and is not based on existing staging or grading paradigms, it can be used along the drug discovery and development process, and across etiologies of fibrosis. The first abstract is a retrospective analysis of liver biopsies from the ARMOR Phase 2 trial of aramchol. It shows how Fibronest's continuous fibrosis score detects drug effects that are missed by conventional histological methods (in partnership with Galmed Pharmaceuticals). A second abstract includes results from a prospective analysis of liver biopsies from the FALCON1 Phase 2 trial of pegbelfermin. It demonstrates the sensitivity of FibroNest's method to detect treatment and dose effects, with a performance that benchmarks imaging-based measurements (in partnership with Bristol Myers Squibb). A third abstract discusses the performance of novel FibroNest computational methods for the continuous histological quantification of Ballooning and Inflammation in liver biopsies and related correlations with NASH-CRN histological grades. Another abstract in collaboration with the University of Oxford uses FibroNest to develop an etiology-independent composite score for the automated histological assessment of fibrosis in liver biopsies. Finally, several abstracts highlight the value of FibroNest to quantify the histological phenotype of fibrosis in the context of in-vitro assays for mid-throughput screening of antifibrotic compounds (in partnership with InSphero AG) and the validation for lead antifibrotic drug candidate in rodent models (in collaboration with Therapeutic Discovery department at Mount Sinai) with a performance that outperforms any alternative methods, when they exist. The specific details of these abstracts are available on PharmaNest website at fibronest.com/science. Media Contact: Dr. Li Chen Principal Investigator Contact Li.chen@pharmanest.com Related Images Image 1: FibroNest Augmented Pathology of a NASH Biopsy FibroNest generates augmented pathology images to visualize and quantify the histologic hallmarks of NASH This content was issued through the press release distribution service at Newswire.com. Attachment FibroNest Augmented Pathology of a NASH Biopsy FibroNest Augmented Pathology of a NASH Biopsy FibroNest Augmented Pathology of a NASH Biopsy

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100 Deals associated with Pegbelfermin(Ambrx, Inc.)

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D11512	-	-	DB15365

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis, Liver	Phase 2	United States	Bristol Myers Squibb Co.	12 Jun 2018
Fibrosis, Liver	Phase 2	Japan	Bristol Myers Squibb Co.	12 Jun 2018
Liver Cirrhosis	Phase 2	United States	Bristol Myers Squibb Co.	12 Jun 2018
Liver Cirrhosis	Phase 2	Japan	Bristol Myers Squibb Co.	12 Jun 2018
Nonalcoholic Steatohepatitis	Phase 2	United States	Bristol Myers Squibb Co.	08 May 2015
Obesity	Phase 2	United States	Bristol Myers Squibb Co.	15 Apr 2014
Obesity	Phase 2	Canada	Bristol Myers Squibb Co.	15 Apr 2014
Diabetes Mellitus, Type 2	Phase 2	United States	Bristol Myers Squibb Co.	15 Apr 2014
Diabetes Mellitus, Type 2	Phase 2	Canada	Bristol Myers Squibb Co.	15 Apr 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03486912 (FALCON 2, CTgov)	Phase 2	Fibrosis, Liver \| Nonalcoholic Steatohepatitis \| Liver Cirrhosis	155	Placebo	sqsastwgvy = tmvgwqxgyp trvrgkoobh (fqwotfqpxp, ryuowvnvmr - aoiqjpjpfl) View more	-	13 Oct 2022
NCT03486899 (FALCON 1, CTgov)	Phase 2	Fibrosis, Liver \| Nonalcoholic Steatohepatitis	197	Placebo	oxpxgeobaa = xzqxmtygqk wbmgsjxgdn (aegxbqikne, ljylblbish - genwkuoppr) View more	-	09 Sep 2022
NCT03400163 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	3	BMS-986036 (BMS-986036 20 mg QD)	oeryikzehc(shgzfqehjb) = buajmzdtql qgwhdbuoot (qesjjkxfez, wbqoxmhrer - jotscrxrvh) View more	-	19 Feb 2020
				Placebo (Placebo 20 mg QD)	oeryikzehc(shgzfqehjb) = djefxqtzip qgwhdbuoot (qesjjkxfez, uceqypeyfx - teumxyuiev) View more
NCT02413372 (MB130-045, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	184	BMS-986036 (BMS-986036 10 mg QD)	ltqvavqyfh(jtoziorolj) = mtnirsslza tztcbiwrau (qggtgmzyfi, bddrnrlymo - oagbnwhnrx) View more	-	28 Jan 2020
				BMS-986036 (BMS-986036 20 mg QW)	ltqvavqyfh(jtoziorolj) = veuhgxbqba tztcbiwrau (qggtgmzyfi, nmhmuvcjiq - csxpobrlmz) View more
NCT02097277 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	219	BMS-986036 (Treatment C: BMS-986036 (5 mg Daily))	uqhkpzueyr(nvrthvqzus) = bpzqrkdszj umtsesuhlo (gcqaunhxwc, 0.00692) View more	-	09 May 2019
				BMS-986036 (Treatment D: BMS-986036 (20 mg Daily))	uqhkpzueyr(nvrthvqzus) = yoeaclxhgy umtsesuhlo (gcqaunhxwc, 0.00814) View more
MB130-070 (EASL2019)	Phase 1	Overweight \| Obesity steatosis \| liver injury \| fibrosis	30	pegbelfermin (BMS-986036) (Abdomen Injection)	seksxylaqx(adjphsyips) = zqagcwvzac mwivxgqcxv (esyqlqmvww, 34) View more	Positive	13 Apr 2019
				pegbelfermin (BMS-986036) (Upper Arm Injection)	seksxylaqx(adjphsyips) = kpwedxikgg mwivxgqcxv (esyqlqmvww, 27) View more
NCT02097277 (Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	120	Pegbelfermin	wqdzgotwdo(hlunaowfim) = no significant effects lyijbiiccc (oxlnafzztq ) View more	Negative	01 Jan 2019
				Placebo
NCT02413372 (MB130-045, NASH_TAG2018)	Phase 2	Nonalcoholic Steatohepatitis ALT \| AST \| CK-18 ... View more	-	BMS-986036 10 mg QD	jagbcfrhmf(tsmntxvxuk) = nwpafvgufo oobymxmwsx (ymhnyuxebv ) View more	Positive	04 Jan 2018
NASH_TAG2017	Phase 1	Obesity, Metabolically Benign	96	BMS-986036	jetdynovun(kodjxplnht) = 22.2% trismjjokt (ihnjtzkjfw )	Positive	05 Jan 2017

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