Approval Probability
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Adjusted LOA
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Pegozafermin · 5 trials · 4 indications
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranges from of 0 to 8, with higher scores indicating worse disease severity. Worsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH Clinical Research Network (CRN) fibrosis score. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
| Arm | Type | Description |
|---|---|---|
| Pegozafermin | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Matched placebo |
| Pegozafermin Regimen 1 | EXPERIMENTAL | - |
| Pegozafermin Regimen 2 | EXPERIMENTAL | - |
| Pegozafermin - 30mg once a week | EXPERIMENTAL | - |
| Pegozafermin - 20mg once a week | EXPERIMENTAL | - |
| Placebo once a week | PLACEBO_COMPARATOR | - |
| Pegozafermin 9 mg QW | EXPERIMENTAL | Participants received pegozafermin 9 mg QW as an SC injection for 8 weeks in the Main Study cohort. |
| Pegozafermin 18 mg QW | EXPERIMENTAL | Participants received pegozafermin 18 mg QW as an SC injection for 8 weeks in the Main Study cohort. |
| Pegozafermin 27 mg QW | EXPERIMENTAL | Participants received pegozafermin 27 mg QW as an SC injection for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion pegozafermin 27 mg QW groups were pooled together due to low sample size in the expansion cohort. |
| Pegozafermin 36 mg Q2W | EXPERIMENTAL | Participants received pegozafermin 36 mg Q2W as an SC injection for 8 weeks in the Main Study cohort. |
| Part 1: Pegozafermin 3 milligrams (mg) weekly (QW) | EXPERIMENTAL | Participants were administered 3 mg of pegozafermin QW, via subcutaneous (SC) injection, starting on Day 1 through Day 85. |
| Part 1: Pegozafermin 9 mg QW | EXPERIMENTAL | Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85. |
| Part 1: Pegozafermin 18 mg QW | EXPERIMENTAL | Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85. |
| Part 1: Pegozafermin 27 mg QW | EXPERIMENTAL | Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85. |
| Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W) | EXPERIMENTAL | Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85. |
| Part 1: Pegozafermin 36 mg Q2W | EXPERIMENTAL | Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85. |
| Part 1: Placebo QW or Q2W | PLACEBO_COMPARATOR | Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85. |
| Part 2: Pegozafermin 27 mg QW | EXPERIMENTAL | Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134. |
| Name | Type | Description |
|---|---|---|
| Pegozafermin | BIOLOGICAL | Subcutaneous injection |
| Placebo | DRUG | Subcutaneous injection |
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirme...
Pegozafermin is an investigational drug being developed for Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Nonalcoholic Steatohepatitis (NASH) with compensated cirrhosis, MASH or NASH with fibrosis, and severe hypertriglyceridemia. It is a monoclonal antibody being studied in Phase 3 clinical trials.
Pegozafermin targets FGF21, a fibroblast growth factor involved in metabolic regulation. By targeting FGF21, the drug aims to address metabolic dysfunction associated with liver disease and hypertriglyceridemia. The drug is being evaluated for its efficacy and safety in patients with MASH, NASH, and severe hypertriglyceridemia.
Pegozafermin is being developed by 89bio, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ETNB. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with MASH, NASH, and severe hypertriglyceridemia.
Pegozafermin is in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA. The drug is investigational and not yet approved, with ongoing trials recruiting participants for MASH and NASH with fibrosis or compensated cirrhosis, and a completed Phase 3 trial in severe hypertriglyceridemia.
Pegozafermin is being studied in two Phase 3 trials: NCT06419374 for MASH with compensated cirrhosis and NCT06318169 for MASH with fibrosis, both recruiting. A Phase 3 trial for severe hypertriglyceridemia (NCT05852431) is completed, as is a Phase 2 trial (NCT04541186) for the same condition.
Yes, Pegozafermin is also known as BIO89-100. A Phase 2 clinical trial (NCT04541186) evaluated the efficacy and safety of BIO89-100, which is Pegozafermin, in participants with severe hypertriglyceridemia. The drug is being developed by 89bio, Inc.