Rockwell Medical has initiated a clinical development program with FPC for the treatment of iron deficiency anemia (IDA) in the home infusion setting. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. Home infusion represents a large and rapidly growing segment of healthcare where we believe FPC may have distinct advantages and improve the treatment standard, helping to meet this very addressable yet unmet clinical need.
Our Phase II study will be the first ever randomized controlled trial of parenteral iron in the home infusion setting.
The home and specialty infusion marketplace is experiencing rapid growth and provides a favorable reimbursement opportunity for suitable drugs. The number of patients served by home infusion therapy has grown from approximately 800,000 in 2010 to over 3,000,000 in 2019.REF
The home infusion setting is expected to continue this rapid expansion, which has been further supported in the COVID-19 environment.
Many patient groups requiring home infusion therapies suffer from diseases that are associated with an incidence of iron deficiency and anemia. For example, it is estimated that 40%-55% of all home parenteral nutrition patients are iron deficient. Current treatment patterns are inadequate for patients on home infusion therapy with IDA. Iron deficiency anemia is also a condition that, if left untreated, is associated with extreme fatigue and can result in serious health risks such as poor immune function and heart failure.
IV iron supplementation is more effective than oral formulations for treatment of moderate to severe IDA, however, concern for adverse events is a deterrent. Home infusion of traditional macromolecular IV iron is limited due to the risk of hypersensitivity and need for medical supervision of the injection and concerns about incompatibility with other infused drugs.
An office visit for infusion of IV iron is costly, inconvenient, and often does not fit the physician practice care model. Limitations with the current approach can lead to a vicious cycle of late diagnosis and treatment, inconsistent follow-up, and increased risk of office visits or hospitalizations.
Based on our data on use of FPC as an anemia treatment for hemodialysis patients, FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options.
We have initiated a development program which includes plans to conduct a Phase 2 clinical study of FPC for the treatment of iron deficiency anemia in home infusion patients.