Nimacimab

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