A first-in-class, only-in-class peripheral antagonist antibody to cannabinoid receptor 1 (CB1) for the treatment of fibrotic, metabolic, and inflammatory diseases including nonalcoholic steatohepatitis (NASH) and diabetic kidney disease (DKD).
CLINICAL
Single Ascending Dose (SAD)
Status: Completed
- Single Ascending Dose (SAD) safety and tolerability profile of nimacimab support advancing to Multiple Ascending Dose (MAD) with 0.6 mg/kg, 1.2 m/kg, and 2.5 mg/kg dose
- PK is dose linear and demonstrates half-life of ~ 14 days
- No clinically meaningful immunogenicity detected
Multiple Ascending Dose (MAD)
Status: In Progress
Study Design
- 3 cohorts of 28 patients each
- 21 nimacimab and 7 placebo per cohort
- Planned doses 0.6 mg/kg, 1.2 mg/kg, and 2.5 mg/kg
- Intravenous dosing
- 4 doses at weekly intervals (0, 1, 2, and 3 weeks)
- Endpoint assessment at 4-5 weeks post-randomization
- PK and ADA will be collected for 45 days post last dose
Multiple exploratory efficacy endpoints
- Change From Baseline
- Liver fat by content as measured by MRI (PDFF) at Day 36
- De novo lipogenesis
- In serum biomarkers including adiponectin, transaminases, and serum lipids
- Oral glucose tolerance testing results
- Inflammatory biomarkers
PHASE 2 MANUFACTURING
Status: In Progress