PARKVILLE, Mo.--(BUSINESS WIRE)--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:
- This was a first-in-human, randomized, double-blind, placebo-controlled, two-arm, crossover study evaluating the safety, tolerability, and efficacy of ascending dose levels of BBI-001 after a single administration.
- BBI-001 or placebo were administered concurrently with a meal enriched with stable iron isotopes which allowed accurate measurement of iron uptake from the gut. All subjects received both BBI-001 and placebo in a randomized cross-over pattern.
- Three dose cohorts of eight patients each were administered 500 mg, 1000 mg, or 2000 mg of BBI-001.
- The results demonstrated BBI-001 was safe and well-tolerated with no reported drug-related adverse events.
- BBI-001 administration resulted in a statistically significant reduction in iron isotope absorption compared to placebo.
- BBI-001 was most effective in participants that had high iron absorption.
“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.
About BBI-001
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.
