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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 Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) with fibrosis, MASH/NASH with compensated cirrhosis, NASH, and severe hypertriglyceridemia. It is currently in Phase 3 clinical trials for these metabolic conditions.
Pegozafermin is a monoclonal antibody being developed by 89bio, Inc. (NASDAQ: ETNB) for metabolic diseases. It is being studied in Phase 3 trials for MASH/NASH with fibrosis and compensated cirrhosis, as well as severe hypertriglyceridemia.
Pegozafermin is being developed by 89bio, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ETNB. The company is conducting Phase 3 clinical trials for the drug in MASH/NASH with fibrosis and compensated cirrhosis.
Pegozafermin is in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA. It is not yet approved and remains investigational, with ongoing trials in MASH/NASH with fibrosis and compensated cirrhosis.
Pegozafermin is being studied in two Phase 3 trials: NCT06318169 (ENLIGHTEN-Fibrosis) in MASH with fibrosis, enrolling 1350 participants, and NCT06419374 in compensated cirrhosis due to MASH, enrolling 762 participants. Both are recruiting and placebo-controlled.
Yes, Pegozafermin is also known as BIO89-100. A Phase 2 trial (NCT04541186) evaluated BIO89-100 in participants with severe hypertriglyceridemia, and a Phase 1 trial (NCT04048135) studied it in NASH or NAFLD.