Bond Biosciences has just announced impressive results from its Phase 1a/b clinical trial involving a groundbreaking new oral treatment for iron overload – BBI-001. The study tested 24 people who were given a single dose in a randomized, double-blind, placebo-controlled setting.
The drug was well-tolerated and there were no noticeable negative side-effects. Beyond that, it was also able to significantly reduce dietary iron absorption, giving the team an excellent stepping stone to move forward with its follow-up Phase II study.
Cory Berkland, the CEO of Bond expressed his enthusiasm surrounding the results and how they could be a much-needed additional solution for eliminating the requirements for phlebotomy treatments in patients with Hereditary Hemochromatosis (HH).
BBI-001 is a revolutionary approach to treating the genetic disorder, Hemochromatosis. Rather than removing two units of blood periodically (therapeutic phlebotomy) to reduce whole body iron stores, this groundbreaking treatment prevents excessive iron uptake from food altogether, potentially eliminating the need for therapeutic phlebotomy altogether. BBI-001 is a game-changer for those living with Hemochromatosis and could revolutionize the lives of those affected by this condition.
Study Design and Summary of Results
This pioneering study was the first to assess the safety, tolerability, and efficacy of the drug BBI-001 in humans. Conducted as a randomized, double-blind, placebo-controlled, two-arm, crossover study, participants were administered a single dose of the medication and its effects were evaluated at gradually increasing doses.
In a randomized cross-over study, the effects of BBI-001 on iron uptake was tested. Subjects were given either the supplement or a placebo alongside a meal enriched with stable iron isotopes, allowing precise determination of iron absorption.
Both BBI-001 and placebo were given in an alternating pattern, giving participants the chance to experience both treatments and revealing the potential power of BBI-001’s impact on iron uptake.
Patients from three different dose cohorts were each given a unique dose of BBI-001 to test its effectiveness. Eight patients in the first cohort were administered 500mg, the second cohort eight patients were administered 1000mg, and the third cohort was administered 2000mg. All participants eagerly awaited the results of the trial to see if BBI-001 could help improve their condition.
The safety and tolerability of BBI-001 was demonstrated in a clinical trial – and the findings were resoundingly positive. No drug-related adverse events were reported. This news is extremely encouraging for the future of this potentially life-changing treatment.
Administration of BBI-001 produced a remarkable reduction in iron isotope absorption, with the difference from placebo being significant from a statistical perspective. This impressive result offers encouraging evidence for the potential of BBI-001 as an effective tool in iron management.
Participants with high iron absorption saw the greatest benefit from treatment with BBI-001, indicating that it is an effective way to address iron deficiencies. Further studies may help to elucidate how BBI-001 impacts other forms of iron absorption.
BBI-001 has proven to be a safe and effective alternative to therapeutic phlebotomy in managing haemochromatosis (HH), which we are thrilled to see. Not only does this new intervention meet a high safety standard, but it may also prove to be more active and accessible than the current methods available. We are truly encouraged by the positive outcomes of the research trial here at Bond and look forward to further innovative options for HH management in the future.
About BBI-001
BBI-001 is an exciting new investigational drug that could be a revolutionary treatment for symptomatic iron overload caused by hereditary hemochromatosis. Unlike other treatments, BBI-001 is administered orally and is designed to quickly create a strong and selective iron chelate in the gastrointestinal tract, preventing the absorption of excess iron. Its unique structure and properties allow it to be safely and effectively confined to the gastrointestinal tract.
About Bond Biosciences
Bond is a revolutionary biopharmaceutical company dedicated to pioneering non-absorbed oral therapies that bind ions within the gastrointestinal tract to alleviate and prevent human illness. Our leading product, BBI-001, is unparalleled, and we continue to launch cutting-edge research projects and treatments that promote a healthier and better quality of life.