Disc Medicine, Inc. (NASDAQ: IRON), a biopharmaceutical company focusing on innovative treatments for severe hematologic diseases, has announced that the United States Food and Drug Administration (FDA) granted Fast Track Designation to DISC-0974 for treating patients with non-dialysis dependent chronic kidney disease (NDD-CKD) and anemia.

Disc Medicine, emphasized the importance of this designation, highlighting the significant need for effective therapies for the millions of NDD-CKD patients with anemia. He stated, "We believe DISC-0974 holds the potential to transform the treatment landscape for these patients, and we look forward to sharing further findings from our ongoing Phase 1b/2 study in NDD-CKD patients with anemia."

Fast Track designation accelerates the development and review of drugs targeting serious conditions with unmet medical needs. It facilitates more frequent interactions between drug developers and the FDA, allowing discussions on the development plan. Drugs with Fast Track designation may also be eligible for priority review and accelerated approval based on clinical data.

DISC-0974 is an investigational monoclonal antibody designed to target hemojuvelin (HJV), a BMP-signaling co-receptor, aiming to suppress hepcidin production and increase serum iron levels in patients with anemia of inflammation. Disc Medicine acquired DISC-0974 from AbbVie in 2019 and has demonstrated clinical proof-of-mechanism in a Phase 1 trial of healthy volunteers. Ongoing clinical studies are assessing DISC-0974 in patients with myelofibrosis and anemia, as well as in patients with NDD-CKD and anemia.

Anemia is a significant complication of chronic kidney disease (CKD), affecting millions worldwide. CKD is characterized by a gradual loss of kidney function and may progress to end-stage renal disease. Anemia results from insufficient red blood cell and hemoglobin production, leading to symptoms such as fatigue, shortness of breath, and reduced physical and cognitive function. Elevated hepcidin levels, driven by inflammation, are a primary cause of anemia in CKD patients, inhibiting erythropoiesis by limiting iron availability. Current treatments for anemia in CKD patients are complex and may pose safety concerns, leaving many patients untreated or reliant on blood transfusions, which come with their own set of risks and limitations.

DISC-0974 represents a promising therapeutic candidate for addressing the unmet medical need in NDD-CKD patients with anemia, and its Fast Track designation underscores its potential to offer a significant advancement in hematologic medicine.

 

Source: globenewswire.com

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