Disc Medicine initiates Phase 1b/2 study of DISC-0974

Disc Medicine announced 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. "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 will be conducted in two parts: Phase 1b: 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; Phase 2: 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.