WATERTOWN, Mass. - Disc Medicine, Inc. (NASDAQ:IRON), a biopharmaceutical company specializing in treatments for hematologic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug DISC-0974. The treatment is aimed at patients with non-dialysis dependent chronic kidney disease (NDD-CKD) who are also suffering from anemia.
This Fast Track status underscores the urgency to address the needs of millions of NDD-CKD anemia patients. DISC-0974, a monoclonal antibody targeting hemojuvelin to suppress hepcidin production, is currently undergoing a Phase 1b/2 study, with additional results expected to be shared within the year.
Anemia of inflammation, a condition often arising in chronic diseases like CKD, leads to elevated hepcidin levels that inhibit iron utilization necessary for red blood cell production. DISC-0974, which was in-licensed from AbbVie (NYSE:ABBV) in 2019, has already shown clinical proof-of-mechanism in a Phase 1 trial with healthy volunteers.
Chronic kidney disease is a prevalent issue affecting over 37 million patients in the United States alone. Anemia associated with CKD can cause fatigue, shortness of breath, and increased mortality risk. Current treatments for anemia in CKD patients are limited due to their complexity and potential safety concerns.
The FDA's Fast Track process aims to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs. Benefits of this designation include more frequent interactions with the FDA and the possibility of priority review and accelerated approval supported by clinical data. However, it is important to note that DISC-0974 is still an investigational agent and has not been approved for therapeutic use.
Disc Medicine is dedicated to advancing treatments for serious hematologic conditions, with a focus on red blood cell biology, including heme biosynthesis and iron homeostasis. The information in this article is based on a press release statement from the company.
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