PARKVILLE, Missouri— Bond Biosciences, Inc., a clinical-stage, privately held biopharmaceutical company today 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.
BBI-001 is a novel investigational new drug. It is a non-absorbed, oral therapeutic designed to rapidly form a strong and selective iron chelate in the digestive tract, thus inhibiting iron absorption in patients with symptomatic iron overload due to HH. The structure and properties of BBI-001 have been designed to restrict it to the GI tract to inhibit systemic expose.
“FDA was very thoughtful in reviewing the Bond briefing package and replying in depth on the proposed non-clinical and clinical development program options, to facilitate the next Phase of clinical development” observed Curtis L. Scribner, MD, Bond’s Chief Medical Officer.
“The FDA’s feedback and guidance on Bond’s 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”, commented Bond’s CSO and Chairman, Dr. Cory Berkland, PhD.
ABOUT BOND BIOSCIENCES, INC.
Bond is a clinical stage, privately held biopharmaceutical company focused on the discovery and development of first-in-class non-absorbed oral therapies that bind excess ions locally in the gastrointestinal (GI) tract to treat or prevent human disease. The Company’s portfolio is comprised of its lead, BBI-001, in addition to other research stage non-absorbed therapies.
Contact
Cory Berkland, CSO, Chairman
[email protected]