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Disc Medicine Receives FDA Fast Track Designation for DISC-0974 for the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
WATERTOWN, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery,
About this update from Disc Medicine, Inc.
[{"type":"text","content":"WATERTOWN, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to DISC-0974 for the treatment of patients with non-dialysis dependent chronic kidney disease (NDD-CKD) and anemia. “Receiving Fast Track designation highlights the unmet need for the millions of NDD-CKD patients with anemia, as well as the potential of DISC-0974 to address this need,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “We believe DISC-0974 could be a transformative therapy for these patients and are excited to share additional results from our ongoing Phase 1b/2 study in NDD-CKD patients with anemia this year.” Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational drugs intended to treat serious conditions and for which nonclinical or clinical data demonstrate the potential to address unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data. About DISC-0974 DISC-0974 is an investigational monoclonal antibody (mAb) targeting a BMP-signaling co-receptor called hemojuvelin (HJV) and is designed to suppress hepcidin production and increase serum iron levels in patients suffering from anemia of inflammation. DISC-0974 was in-licensed by Disc from AbbVie in 2019. Anemia of inflammation arises from abnormally elevated hepcidin and affects millions of patients in the US across numerous diseases such as chronic kidney disease, myelofibrosis, cancer, autoimmune diseases, and other conditions with an inflammatory component. Disc has established clinical proof-of-mechanism of DISC-0974 in a Phase 1 trial of healthy volunteers and has ongoing clinical studies of DISC-0974 in patients with myelofibrosis and anemia and also in patients with NDD-CKD and anemia. DISC-0974 is an investigational agen...