Rockwell Medical Announces Growth Plan and New Therapeutic Opportunities for Its Ferric Pyrophosphate Citrate (FPC) Platform - Seite 2

Dr. Ellison added: “In addition, we discussed potentially pursuing an indication for FPC in hospitalized patients with acute heart failure. We believe FPC could be uniquely suited for these patients, based upon a completed mechanistic proof-of-concept study and the immediately bioavailable iron that FPC can deliver to patients during a short hospital stay. We continue to evaluate this opportunity and anticipate holding a Type C meeting with the FDA in the second half of 2021 to discuss the pathway for a potential clinical development program.”

Highlights from the conference call and webcast are as follows:

Home Infusion

• Home infusion therapy is a rapidly growing area of medicine, with over 3.2 million patients served in 2019. We believe the growth trend is likely to continue driven by cost savings versus office-based or hospital care, an improving reimbursement landscape, and emerging standards resulting from the COVID-19 pandemic.
• IDA is a common co-morbidity in many sub-groups of patients receiving home infusion therapy, particularly in those receiving long-term home parenteral nutrition (HPN).
• Management of IDA in home infusion patients is currently a ‘broken’ process, according to the National Home Infusion Association, due to limitations with currently available parenteral iron products and other factors.
• FPC is uniquely suited for the treatment of IDA in the home infusion population based upon its kinetic profile and outstanding safety profile in both clinical trials and post-marketing use, and may fill an unmet clinical need as a uniquely suitable home infusion therapy for treatment of IDA.
• Home infusion therapy patients with IDA may be candidates for treatment with FPC across additional therapeutic categories besides HPN. These categories include antineoplastic chemotherapy, hydration therapy, inotropics and biologics. The U.S. market opportunity for HPN is estimated to be $200 million per year, and the U.S. market opportunity for the other categories above is estimated to be $400 million per year.
• The majority of home infusion therapy patients are covered by commercial insurance, and payers are increasingly motivated to reimburse home infusions to reduce in-office visits and hospitalizations, and save costs.
• Rockwell Medical intends to hold a Type C meeting with the FDA in Q1 2021 to discuss the pathway for clinical development. The Company anticipates conducting a Phase II observational study and a dose scheduling study to achieve proof-of-concept, with the goal of ultimately securing a broad label claim of treatment of IDA in adult patients receiving home infusion therapy regardless of etiology.
• The Company expects Phase II data around the end of 2021.

Acute Heart Failure