Disc Medicine has initiated a Phase Ib/II trial of its investigational monoclonal antibody (mAb) DISC-0974 in non-dialysis dependent chronic kidney disease (NDD-CKD) anaemia patients.
The antibody inhibits the hemojuvelin (HJV) co-receptor to suppress hepcidin, and thereby addresses anaemia by improving the availability of iron for erythropoiesis.
The multi-centre, Phase Ib/II trial will assess DISC-0974’s tolerability, safety, and efficacy in NDD-CKD patients with anaemia.
Hepcidin levels, serum iron, and markers of iron mobilisation, along with changes in haemoglobin, will be included as the trial’s endpoints.
Enrollment criteria for the study will include patients with Stage II-V CKD not on dialysis, with a baseline Hb < 11.0 g/dL for males and Hb < 10.5 g/dL for females.
The trial will also include patients who are not receiving concurrent treatment with erythropoietin-stimulating agents (ESAs).
Disc Medicine CEO John Quisel said: “There is a tremendous need for innovative therapies that work through mechanisms outside of the erythropoietin pathway.
“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.”
In the Phase Ib dose-escalation part of the trial, single, ascending DISC-0974 doses will be administered subcutaneously at 28mg, 40mg, 60mg, and 90mg levels.
At each dose level, safety, PK, and haematologic effects will be assessed in this randomised, double-blind, placebo-controlled trial.
Based on optimal increases in haemoglobin, a dose for the expansion phase will be selected.
The Phase Ib/II trial’s Phase II expansion stage will have an open-label, single-arm study design. Participants will receive multiple DISC-0974 doses subcutaneously, once-a-month at the dose level that is selected from the Phase Ib portion for three months.
DISC-0974 is also being studied in a Phase Ib/II clinical trial in myelofibrosis and anaemia patients.