A Phase 2 multiple ascending dose clinical study of BBI-001 for treatment of iron overload associated with hereditary hemochromatosis
Latest Information Update: 19 Jan 2024
At a glance
- Drugs BBI-001 (Primary)
- Indications Haemochromatosis
- Focus Adverse reactions
Most Recent Events
- 19 Jan 2024 New trial record
- 11 Jan 2024 According to a Bond Biosciences media release, the FDAs feedback and guidance on Bonds Chemistry, Manufacturing, and Controls (CMC) and clinical protocol design for BBI-001 provides a clear pathway to IND submission in the fourth quarter of 2024 to initiate the Phase 2 clinical trial
- 11 Jan 2024 According to a Bond Biosciences media release, company announced a successful meeting with the U.S. Food and Drug Administration (FDA) following a scheduled pre-IND meeting with the Office of Cardiology, Hematology, Endocrinology, and Nephrology, Division of Nonmalignant Hematology to seek advice on the BBI-001 development program in support of a Phase 2 multiple ascending dose clinical trial to further assess the safety and iron biomarkers in hereditary hemochromatosis (HH) patients.