Bond Biosciences Announces First Dosing of Sentinel Patients in a Phase Ia/b Clinical Trial for a Novel Therapy to Treat Patients with Hemochromatosis
This trial is a first-in-human Phase Ia/b Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study Enrolling Healthy Anemic and Hemochromatosis patients across three cohorts to assess safety, tolerability, and pharmacodynamic effect of BBI-001.
PARKVILLE, Mo.--(BUSINESS WIRE)--Bond Biosciences, Inc.
“We are pleased to begin this first-in-human clinical trial of our lead non-absorbed oral therapy and thankful for the seasoned development team that contributed to this significant milestone,” said Dr. Cory Berkland, Bond’s CEO, Chairman of the Board and Co-founder. “We believe BBI-001 has the potential to reduce or eliminate the need for lifelong therapeutic phlebotomy and we are excited to bring this pharmaceutical one step closer to approval."
Bond’s clinical lead, BBI-001, an investigational new drug, is designed as a non-absorbed oral therapeutic to bind dietary iron and inhibit iron absorption in patients that suffer from iron overload. As they age, patients with excess iron in their organs are at an increased risk of, among other diseases, accelerated aging, diabetes, liver disease, heart failure, certain cancers, joint pain, and metabolic diseases.
“In addition to safety and tolerability, the study has been designed to provide proof of mechanism data for BBI-001,” said Michael Riley, Bond’s Chief Operating Officer, Member of the Board and Co-founder. “Positive human proof of mechanism data will further reinforce our conviction that BBI-001 can help patients that suffer from iron overload.”
About the Clinical Study
This Phase Ia/b will assess the safety of BBI-001 and test the ability of BBI-001 to prevent iron uptake from food. Subjects with Hereditary Hemochromatosis (HH) or iron deficiency will be randomized to receive BBI-001 or placebo before a meal supplemented with one of two naturally occurring, non-radioactive iron isotopes. The hypothesis being that BBI-001 will bind iron in the gut and prevent iron absorption into the body while the placebo will not. If this is demonstrated, clinical studies will be expanded to treat HH subjects who require regular therapeutic phlebotomy to manage iron overload.
BBI-001 is a novel investigational new drug that is designed as a non-absorbed oral therapeutic to rapidly and selectively bind iron with high avidity in the digestive tract to significantly reduce iron absorption in patients that suffer from iron overload due to HH. Its design to be restricted to the GI tract should maximize safety and speed regulatory approval. HH is a genetic disorder characterized by excessive intestinal absorption of iron from food resulting in a pathological increase in total body iron.
About Bond Biosciences
Bond is a privately held biopharmaceutical company focused on the discovery and development of first-in-class non-absorbed oral therapies that function locally in the gastrointestinal 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.
Cory Berkland, CEO