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 Jan 2026·HEPATOLOGY

Comparative efficacy of pharmacologic therapies for MASH in reducing liver fat content: Systematic review and network meta-analysis

Review

Author: Nah, Benjamin ; Seko, Yuya ; Ramadoss, Vijay ; Noureddin, Mazen ; Takahashi, Hirokazu ; Ng, Cheng Han ; Xiao, Jieling ; Nakajima, Atsushi ; Koh, Benjamin ; Sim, Benedix Kuan Loon ; Teng, Margaret ; Huang, Daniel Q. ; Danpanichkul, Pojsakorn ; Teo, Chong Boon ; Gunalan, Shyna Zhuoying ; Lim, Mei Chin ; Muthiah, Mark ; Law, Michelle ; Wijarnpreecha, Karn ; Loomba, Rohit ; Tan, En Ying

Background and Aims::

Metabolic dysfunction–associated steatohepatitis (MASH) is a leading cause of liver disease. Dynamic changes in MRI proton-density-fat fraction (PDFF) are associated with MASH resolution. We aimed to determine the relative efficacy of therapeutic agents for reducing hepatic fat, assessed by MRI-PDFF.

Approach and Results::

In this systematic review and network meta-analysis, we searched MEDLINE and Embase from inception until December 26, 2023, for published randomized controlled trials comparing pharmacological interventions in patients with MASH that assessed changes in MRI-PDFF. The primary outcome was the absolute change in MRI-PDFF. The secondary outcome was a ≥30% decline in MRI-PDFF. A surface under-the-curve cumulative ranking probabilities (SUCRA) analysis was performed. Of 1550 records, a total of 39 randomized controlled trials (3311 participants) met the inclusion criteria. For MRI-PDFF decline at 24 weeks, aldafermin (SUCRA: 83.65), pegozafermin (SUCRA: 83.46), and pioglitazone (SUCRA: 71.67) were ranked the most effective interventions. At 24 weeks, efinopegdutide (SUCRA: 67.02), semaglutide + firsocostat (SUCRA: 62.43), and pegbelfermin (SUCRA: 61.68) were ranked the most effective interventions for achieving a ≥30% decline in MRI-PDFF.

Conclusions::

This study provides an updated, relative rank-order efficacy of therapies for MASH in reducing hepatic fat. These data may help inform the design and sample size calculation of future clinical trials and assist in the selection of combination therapy.

01 Jan 2026·JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Efficacy and safety of fibroblast growth factor 21 analogs in metabolic dysfunction–associated steatotic liver disease and metabolic dysfunction–associated steatohepatitis: A systematic review and network meta-analysis

Review

Author: Abouelmagd, Khaled ; Taha, Nouran A ; Fareed, Areeba ; Keshk, Menna ; Ali, Shujaat ; Taha, Amira Mohamed ; Khan, Misha ; Hasan, Mohammed Tarek ; Abdelkader Saed, Sara Adel ; Abdeljawad, Marwa Muhammed

Metabolic dysfunction-associated steatotic liver disease has emerged as a global public health concern. Fibroblast growth factor 21, a liver hormone, is gaining interest because of its ability to regulate metabolism and improve metabolic dysfunction-associated steatotic liver disease. In this network meta-analysis, we investigated the efficacy of these treatments in treating metabolic dysfunction-associated steatotic liver disease. A comprehensive search was conducted across electronic databases, including PubMed, Scopus, the Cochrane Library, and Web of Science, till August 2025. We used R software to analyze data using a random effects model. Heatmaps were used to visualize the included interventions' ranking. We included 9 clinical trials comprising 1277 patients. Among them, 284 received efruxifermin, 263 received pegbelfermin, 151 received pegozafermin, 65 received efimosfermin, 139 received MK-3655, and 375 received a placebo. Pegozafermin and efruxifermin were effective in improving liver fibrosis (RR, 3.89-3.93, P < .05; RR, 2.23-1.91, P < .05, respectively), whereas the other interventions did not yield statistical significance. Efimosfermin α, efruxifermin, and pegozafermin improved different metabolic parameters, including adiponectin, hemoglobin A1c, and non-high-density lipoprotein. However, no significant differences were observed in body weight and low-density lipoprotein. For liver enzymes, efimosfermin α had the greatest reduction of alanine aminotransferase and aspartate aminotransferase, whereas efruxifermin was most effective in reducing γ-glutamyl transferase levels. The odds of adverse events were higher in pegozafermin, efimosfermin, and efruxifermin groups, mainly attributed to mild to moderate gastrointestinal adverse events. In conclusion, efruxifermin and pegozafermin are promising therapeutic options with a tolerable adverse event profile; meanwhile, efimosfermin α showed promising results in improving metabolic parameters, with histologic results yet to be published. SIGNIFICANCE STATEMENT: This meta-analysis evaluates the efficacy of fibroblast growth factor 21 analogs in improving metabolic dysfunction-associated steatotic liver disease. Efruxifermin and pegozafermin were the most significant in improving liver fibrosis; moreover; significant improvements in some metabolic parameters were observed with efimosfermin α, efruxifermin, and pegozafermin.

04 Aug 2025·CURRENT PHARMACEUTICAL DESIGN

FGF21 Analogues and MASLD: A Summary of Preclinical and Clinical Data

Article

Author: Papalavrentios, Lavrentis ; Boutari, Chrysoula ; Sinakos, Emmanouil ; Triantafyllou, Achilleas ; Goulis, Ioannis

Abstract::

Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) is the most frequent chronic liver disease, which is closely associated with metabolic syndrome and obesity. Although it has now reached epidemic proportions, the treatment of this disease remains a challenge. Currently, there is only one drug approved for metabolic dysfunction-associated steatohepatitis (MASH), and various pharmaceutical agents have reached phase 3 of clinical trials and appear as potential drugs for the disease. Fibroblast Growth Factor (FGF) 21 has been gaining increasing interest as a possible therapeutic target for MASLD. FGF21 analogues, with an improved pharmacodynamic and pharmacokinetic profile, exert pleiotropic, favorable effects on liver function and histology, as well as systemic metabolism. They also appear to be effective in alleviating hepatic steatosis, steatohepatitis, and fibrosis in MASH. Among various others, efruxifermin, pegozafermin, pegbelfermin, and BOS-580 are FGF-21 analogues that have resulted in significant improvements in liver fat, fibrosis, and measures of liver function in the context of phase 2 clinical trials. This review summarizes the preclinical and clinical data from FGF21 analogues for MASLD and MASH.

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

Collaborate

100 Deals associated with Pegbelfermin(Ambrx, Inc.)

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KEGG	Wiki	ATC	Drug Bank
D11512	-	-	DB15365

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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
Metabolic Dysfunction Associated 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 \| Metabolic Dysfunction Associated Steatohepatitis \| Liver Cirrhosis	155	Placebo	hcfvtjdtzf = tndcffnwky yqdvvxhsvb (nxbhclydqn, sybeivwxsp - zxrbhakavc) View more	-	13 Oct 2022
NCT03486899 (FALCON 1, CTgov)	Phase 2	Fibrosis, Liver \| Metabolic Dysfunction Associated Steatohepatitis	197	Placebo	hluneyqnmd = wdrkomeboc oroffntbug (zhehzmbwfy, cxwuutcttc - wrukuyfxen) View more	-	09 Sep 2022
NCT03400163 (CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	3	BMS-986036 (BMS-986036 20 mg QD)	pvbgydlkts(fqsyyxsioi) = fqpybtrono wtflxhjebk (kbepzvxqne, phcdqgztbk - subahnmkpj) View more	-	19 Feb 2020
				Placebo (Placebo 20 mg QD)	pvbgydlkts(fqsyyxsioi) = stnbppdcfr wtflxhjebk (kbepzvxqne, rkfnbzwkii - eqegxfxhvx) View more
NCT02413372 (MB130-045, CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	184	BMS-986036 (BMS-986036 10 mg QD)	dwiksredqj(xqlzyrlecc) = gpmmrvnoiu dhdlhxhage (lqriytckmg, tpxexqzmpc - nbbdnqarpy) View more	-	28 Jan 2020
				BMS-986036 (BMS-986036 20 mg QW)	dwiksredqj(xqlzyrlecc) = eryonyehor dhdlhxhage (lqriytckmg, ovwimtkqyl - kjgmybpkur) View more
NCT02097277 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	219	BMS-986036 (Treatment C: BMS-986036 (5 mg Daily))	xmvogxfbpx(imwhhyizlx) = mczevgvyfe rolhxomfpn (upnypamaai, 0.00692) View more	-	09 May 2019
				BMS-986036 (Treatment D: BMS-986036 (20 mg Daily))	xmvogxfbpx(imwhhyizlx) = ayitkzphhh rolhxomfpn (upnypamaai, 0.00814) View more
EASL2019	Phase 1	Overweight \| Obesity steatosis \| liver injury \| fibrosis	30	pegbelfermin (BMS-986036) (Abdomen Injection)	iqnuobklzu(xkhlpkqexd) = vbqcmoxsnl tmlfpmbspt (zhwvenhlmo, 34) View more	Positive	13 Apr 2019
				pegbelfermin (BMS-986036) (Upper Arm Injection)	iqnuobklzu(xkhlpkqexd) = lxkyfcgepr tmlfpmbspt (zhwvenhlmo, 27) View more
NCT02097277 (Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	120	Pegbelfermin	ahqpmlqoiu(zbpixhiagl) = no significant effects qdrvgeyptn (gkfxswzgqq ) View more	Negative	01 Jan 2019
				Placebo
NCT02413372 (MB130-045, NASH_TAG2018)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis ALT \| AST \| CK-18 ... View more	-	BMS-986036 10 mg QD	tcgkelkmwg(pougmxzvbq) = dfmigcsoyi vitvqbjayd (ocgfunvpvq ) View more	Positive	04 Jan 2018
Phase 1 Study of BMS-986036 (NASH_TAG2017)	Phase 1	Obesity, Metabolically Benign	96	BMS-986036	zjclfahgkx(lqpgbjfnqz) = 22.2% sqlqgltlls (vcaxwuqbeh )	Positive	05 Jan 2017

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