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Disc Medicine Initiates a Phase 1b/2 Clinical Study of DISC-0974 in Adults with Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) and Anemia
WATERTOWN, Mass., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Disc Medicine, a clinical-stage biopharmaceutical company focused on the discovery, development and
About this update from Disc Medicine, Inc.
[{"type":"text","content":"WATERTOWN, Mass., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Disc Medicine, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from serious hematologic diseases, announced today the initiation of a Phase 1b/2 clinical study of DISC-0974 in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with anemia. DISC-0974 is a monoclonal antibody designed to suppress hepcidin by inhibiting the hemojuvelin (HJV) co-receptor, and thereby address anemia by enhancing the availability of iron for erythropoiesis. DISC-0974 is also currently being studied in a Phase 1b/2 clinical study in patients with myelofibrosis and anemia. “We are excited to initiate this clinical trial of DISC-0974 in chronic kidney disease, where hepcidin plays a key role in the pathophysiology of anemia. There is a tremendous need for innovative therapies that work through mechanisms outside of the erythropoietin pathway,” said John Quisel, JD, PhD, Chief Executive Officer at Disc Medicine. “We believe DISC-0974 has potential across a broad range of chronic and inflammatory diseases. With the start of this study, we now have ongoing clinical trials for DISC-0974 in both chronic kidney disease and myelofibrosis, and plan to explore its use in other indications as well.” The study will be a multi-center, Phase 1b/2 trial and will evaluate the safety, tolerability, and efficacy of DISC-0974 in NDD-CKD patients with anemia. The study endpoints will include hepcidin levels, serum iron and markers of iron mobilization and changes in hemoglobin. The study enrollment criteria will include patients with Stage II-V CKD not receiving dialysis, baseline Hb Phase 1b (Dose-Escalation): Randomized, double-blind, placebo-controlled study design; single, ascending doses of DISC-0974 will be administered subcutaneously at the following planned dose levels: 28 mg, 40 mg, 60 mg, 90 mg; safety, PK and hematologic effects will be assessed at each dose level; a dose for the expansion phase will be selected based on optimal increases in hemoglobin;Phase 2 (Expansion Stage): Open-label, single-arm study design; multiple doses of DISC-0974 administered subcutaneously, once-monthly at the dose level selected from the phase 1b portion of the study for three months. About DISC-0974 DISC-0974 is an inv...