BBI-001 was well tolerated with no dose limiting toxicities.
Single-dose administration demonstrated a statistically significant reduction of dietary iron absorption.
July 20, 2023 12:00 AM Eastern Daylight Time
Bond Biosciences (“Bond” or “the Company”) announced positive clinical results today from its 24-person Phase 1a/b, randomized, double-blind, placebo-controlled, single-ascending-dose study that assessed the safety, tolerability, and pharmacodynamic activity of BBI-001, a first-in-class, non-absorbed oral treatment in development for the treatment of iron overload. BBI-001 was well-tolerated and exhibited no drug-related adverse events while significantly reducing dietary iron absorption. Cory Berkland, Chief Executive Officer of Bond, commented that “we are highly encouraged by these results, which demonstrate the mechanism and clinical activity of BBI-001 after just a single dose. The results pave the way for our planned Phase II study to investigate the effectiveness of BBI-001 in reducing or eliminating the need for phlebotomy in adult participants with Hereditary Hemochromatosis (HH). Completing this trial on such a positive note is an important step toward serving the patients who need an additional safe and effective solution for managing their disease”.
HH is a genetic disorder characterized by excessive intestinal absorption of iron from food resulting in a pathological increase in total body iron. The current standard of care is to decrease whole body iron stores by periodically removing two units of blood (therapeutic phlebotomy). BBI-001 is designed to prevent excessive iron uptake from food to decrease or potentially eliminate the need for therapeutic phlebotomy.
Study Design and Summary of Results:
“Since therapeutic phlebotomy is a safe method for managing HH, any new intervention must have an impeccable safety profile. I am very pleased by the results of this trial, which showed BBI-001 to meet this high safety standard while also suggesting it may act as an active and ultimately convenient alternative to therapeutic phlebotomy.” said Curtis L. Scribner, MD, Bond’s Chief Medical Officer.
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 are designed to restrict it to the GI tract to maximize safety.
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 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.