Drugs / Pegozafermin
Pegozafermin
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05022693 | Aug → Dec 2021 | metabolic dysfunction-associated steatohepatitis | 89bio, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT04048135 | Jul 2019 → Aug 2020 | metabolic dysfunction-associated steatohepatitis | 89bio, Inc. | Completed | Met primary |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT04929483 | Jun 2021 → Feb 2023 | metabolic dysfunction-associated steatohepatitis | 89bio, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04541186 | Sep 2020 → May 2022 | — | 89bio, Inc. | Completed | Met primary |
| Phase 33 trials | ||||||
| Phase 3 | NCT06419374 | May 2024 → Jun 2028 expected | metabolic dysfunction-associated steatohepatitis | 89bio, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06318169 | Mar 2024 → Feb 2029 expected | metabolic dysfunction-associated steatohepatitis | 89bio, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05852431 | Jun 2023 → Jul 2025 | — | 89bio, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2024-11-15 | 89bio, Inc. | Results 89bio Presents New Analyses Evaluating Pegozafermin and Potential Benefit of Non-Invasive Tests from the ENLIVEN Phase 2b Trial in MASH Patients at AASLD The Liver Meeting® 2024 89bio.com ↗
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, announced new analyses of data from the Phase 2b ENLIVEN trial evaluating pegozafermin in metabolic dysfunction-associated steatohepatitis (MASH) patients with advanced fibrosis. |
| 2024-05-22 | 89bio, Inc. | Results 89bio to Present 48-Week Data from ENLIVEN Phase 2b Pegozafermin Trial in Metabolic Dysfunction-Associated Steatohepatitis (MASH) at EASL International Liver Congress 89bio.com ↗ |
| 2024-03-27 | 89bio, Inc. | Regulatory 89bio Receives EMA PRIME Status for Pegozafermin in the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Fibrosis and Compensated Cirrhosis 89bio.com ↗
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with MASH. |
| 2023-12-04 | 89bio, Inc. | Regulatory 89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024 89bio.com ↗
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced a successful end-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), supporting the advancement of pegozafermin into Phase 3 in NASH. |
| 2023-11-27 | 89bio, Inc. | Results 89bio Announces New Positive Long-Term Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH) 89bio.com ↗
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced positive topline data from the blinded extension phase of its Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH). |
| 2023-11-12 | 89bio, Inc. | Results 89bio Announces Additional Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Compensated Cirrhotic (F4) Nonalcoholic Steatohepatitis (NASH) at AASLD The Liver Meeting® 2023 89bio.com ↗ |
| 2023-09-21 | 89bio, Inc. | Regulatory 89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in Nonalcoholic Steatohepatitis (NASH) 89bio.com ↗
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin in patients with nonalcoholic steatohepatitis (NASH). |
| 2023-06-24 | 89bio, Inc. | Results Data from 89bio’s ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH) Published in The New England Journal of Medicine and Simultaneously Presented in a Late-breaker Session at the EASL International Liver Congress 89bio.com ↗
ENLIVEN results demonstrated that treatment with pegozafermin 30mg weekly and 44mg every-two-week doses resulted in statistically significant changes on both primary histology endpoints |
| 2023-06-24 | 89bio, Inc. | Results 89bio Publishes Positive Results from Phase 2 ENTRIGUE Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG) in Nature Medicine 89bio.com ↗ |
| 2023-03-22 | 89bio, Inc. | Results 89bio’s Phase 2b ENLIVEN Trial of Pegozafermin in Nonalcoholic Steatohepatitis (NASH) Achieved High Statistical Significance on Both Primary Histology Endpoints with Weekly (QW) and Every-Two-Week (Q2W) Dosing at 24 Weeks 89bio.com ↗ |
| 2023-03-04 | 89bio, Inc. | Results 89bio Presents New Analysis of Data from Phase 2 ENTRIGUE Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG) at American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology 89bio.com ↗
Results of the post hoc analysis of lipid effects of pegozafermin among study participants based on their lipid-modifying background therapy status demonstrated that pegozafermin significantly reduced TG and other atherogenic lipids after eight weeks of therapy. |
| 2022-12-12 | 89bio, Inc. | Results 89bio Announces Publication of Results of Phase 1b/2a Study of Pegozafermin for the Treatment of NASH in The Lancet Gastroenterology & Hepatology 89bio.com ↗
Study results showed statistically significant absolute reductions in hepatic fat fraction at week 13 with pegozafermin administered every week or every two weeks compared to placebo. |
| 2022-11-05 | 89bio, Inc. | Results 89bio Presents Additional Exploratory Analyses from the Phase 1b/2a NASH Study of Pegozafermin at AASLD The Liver Meeting® 2022 89bio.com ↗
New analysis of cohort 7 data using a three-reader pathologist panel showed that 6/19 patients scored as having fibrosis stage 4 at baseline (putative F4); excluding these patients resulted in higher histological response rates in the patients with F2-F3 fibrosis than previously reported |
| 2022-08-26 | 89bio, Inc. | Results 89bio Presents Positive Results from ENTRIGUE Phase 2 Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG) at European Society of Cardiology Congress 2022 89bio.com ↗
These data build on the growing body of evidence demonstrating that treatment with pegozafermin can significantly reduce triglycerides (TG), reduce atherogenic lipoproteins, and improve liver fat and glycemic control markers in patients with SHTG, |
| 2022-06-28 | 89bio, Inc. | Results 89bio Reports Positive Topline Results from ENTRIGUE Phase 2 Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG) 89bio.com ↗
89bio, Inc. (Nasdaq: ETNB), today announced positive topline results from ENTRIGUE, the Phase 2 proof-of-concept study evaluating pegozafermin for the treatment of severe hypertriglyceridemia (SHTG). |
| 2022-01-24 | 89bio, Inc. | Results 89bio Reports Positive Topline Results from an Expansion Cohort of the Phase 1b/2a Trial of Pegozafermin (BIO89-100) for the Treatment of NASH 89bio.com ↗ |
| 2021-11-14 | 89bio, Inc. | Results 89bio Presents New Data from Phase 1b/2a NASH Study Showing BIO89-100 Reduces Spleen Volume 89bio.com ↗
The sub-analysis, which assessed the correlation between liver fat and spleen volume (SV), demonstrated that treatment with BIO89-100 reduced spleen volume by an average of 11.8% in patients with NASH. |
| 2021-10-25 | 89bio, Inc. | Results 89bio to Present New Sub-Analysis from Phase 1b/2a NASH Study of BIO89-100 at AASLD’s The Liver Meeting 2021 89bio.com ↗
Data from a new sub-analysis of the Phase 1b/2a study in NASH shows correlation between increased liver fat and spleen volume in patients with non-cirrhotic NASH |
| 2021-03-20 | 89bio, Inc. | Results 89bio Presents Additional Analysis of Phase 1b/2a NASH Study at the Annual ENDO 2021 Conference 89bio.com ↗
We are encouraged by new analyses from our Phase 1b/2a study that show BIO89-100 demonstrated clinically meaningful reductions in both liver fat volume and liver volume overall across all dosing groups. |
| 2020-11-13 | 89bio, Inc. | Results 89bio Presents Updated Clinical Data from Positive Phase 1b/2a Study of BIO89-100 in NASH at AASLD’s The Liver Meeting® 2020 89bio.com ↗ |
| 2020-09-14 | 89bio, Inc. | Results 89bio Announces Positive Topline Results from its Phase 1b/2a Trial of BIO89-100 in NASH 89bio.com ↗
89bio, Inc. (Nasdaq: ETNB) today announced positive topline results from its Phase 1b/2a trial with BIO89-100, an investigational FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). |
| 2019-11-11 | 89bio, Inc. | Results 89bio Announces Presentations of BIO89-100 Data at The Liver Meeting® 2019 89bio.com ↗
The poster presentations will include results from the Phase 1a clinical trial in healthy volunteers demonstrating that BIO89-100 was generally well tolerated at single doses up to 78 mg with a generally dose-proportional pharmacokinetic profile allowing for a weekly or every two-week dosing. |
| 2019-05-22 | 89bio, Inc. | Results 89bio Reports Positive Top-line Data from Phase 1 Single-Ascending Dose Clinical Trial of BIO89-100, an Investigational Medicine for NASH 89bio.com ↗ |
| 2019-04-11 | 89bio, Inc. | Results 89bio Announces Preclinical Data That Demonstrate Potential Utility of BIO89-100 for Treatment of NASH 89bio.com ↗
In this preclinical study in spontaneously diabetic obese cynomolgus monkeys, BIO89-100 demonstrated statistically significant pharmacodynamic effects on key metabolic and liver parameters associated with NASH following weekly and every 2-week subcutaneous dosing. |
All press releases naming this drug 40 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegozafermin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04048135 ↗ |
| Known as | BIO89-100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05022693 ↗ |
| Known as | Pegozafermina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594466 ↗ |
| Known as | Pegozafermine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594466 ↗ |
| Known as | TEV-47948 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594466 ↗ |
| Modality | Protein / enzyme biologic | “Pegozafermin is a long-acting glycoPEGylated analog of fibroblast growth factor 21 (FGF21)” PMID 37696614 ↗ Oct 2023 |
| Route | Subcutaneous | “via subcutaneous (SC) injection” NCT04048135 ↗ |