Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04929483 | Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 222 | — | — | Jun 4, 2021 | Oct 8, 2024 | Jan 6, 2026 | 89 | United States, Puerto Rico |
| NCT05022693 | PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis | PHASE1 | COMPLETED | 8 | — | — | Aug 16, 2021 | Dec 21, 2021 | Mar 2, 2022 | 1 | United States |
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...