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BIO89-100 · 2 trials · 1 indication
Nonalcoholic fatty liver disease activity score (NAS) was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Resolution of NASH was defined as the total absence of ballooning (score=0) and absent or mild inflammation (score=0 to 1). NASH clinical research system (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). Worsening of fibrosis was defined as progression of fibrosis greater than or equal to (≥) 1 stage in NASH CRN fibrosis score.
Worsening of NASH was defined as increase in nonalcoholic fatty liver disease activity score (NAS) for ballooning, inflammation, or steatosis. NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score. NASH CRN fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
Determine maximum observed serum drug concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| BIO89-100 - 15 mg once weekly (QW) | EXPERIMENTAL | - |
| BIO89-100 - 30 mg QW | EXPERIMENTAL | - |
| BIO89-100 - 44 mg once every 2 weeks (Q2W) | EXPERIMENTAL | - |
| Placebo QW | PLACEBO_COMPARATOR | - |
| Placebo Q2W | PLACEBO_COMPARATOR | - |
| Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension) | EXPERIMENTAL | - |
| BIO89-100 30 mg, Open Lable, Single Dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BIO89-100 | DRUG | Subcutaneous injection |
| Placebo | DRUG | Subcutaneous injection |
Key Inclusion Criteria: * Age 21 to 75 * Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. * Qualifying biopsy must be either within 6 months of screening visit or...
BIO89-100 is an investigational drug being developed for the treatment of Nonalcoholic Steatohepatitis (NASH), a condition characterized by liver inflammation and damage. It is currently in clinical development and has not been approved by regulatory authorities.
BIO89-100 is being developed by 89bio, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ETNB. 89bio is focused on developing therapies for metabolic and liver diseases.
BIO89-100 is in Phase 2 clinical development. It has completed a Phase 2 trial and a Phase 1 trial. The drug is investigational and has not been approved for commercial use.
BIO89-100 has completed two clinical trials. The Phase 2 trial (NCT04929483) enrolled 222 participants with biopsy-confirmed NASH, while the Phase 1 trial (NCT05022693) enrolled 8 participants with NASH and compensated cirrhosis. Both trials were completed in the United States and Puerto Rico.
BIO89-100 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being studied specifically for NASH and is not known to be marketed under any other brand name.