Cystic Fibrosis

Phase 2 Cystic Fibrosis Trial

Corbus Pharmaceuticals has completed a phase 2, double-blind, randomized, placebo-controlled multicenter study that evaluated safety, tolerability, pharmacokinetics, and efficacy of JBT-101 (also known as Anabasum) in cystic fibrosis.

Study participants were screened for up to 28 days to ensure they met study entry criteria. Following the initial screening, participants were provided with a dose of Anabasum or placebo for once a day dosing for 28 days. On the 29th day, participants switched to twice a day dosing for an additional 56 days. The total treatment period was 84 days. After the treatment period, participants were followed for an additional 28 days.

  • Primary Endpoints: Safety and tolerability
  • Secondary Endpoints: Trends in efficacy (FEV1, lung clearance index, CFQ-R respiratory symptom score) and pharmacokinetics
  • Eligibility:
    • Ages eligible for study: 18 years to 62 years
    • Genders eligible for study: both
  • Inclusion Criteria:
      • Documentation of a CF diagnosis:
        • Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test; or
        • Two well-characterized mutations in the CFTR gene
    • FEV1 ≥ 40% predicted corrected
    • Stable treatment of CF for 14 days before Visit 1

Anabasum (JBT-101) MOA in Cystic Fibrosis

Study News