Disc Medicine has commenced a Phase I study of the DISC-3405 monoclonal antibody in healthy volunteers.
The single and multiple-ascending dose, placebo-controlled, double-blind, randomised study will assess the pharmacokinetics, tolerability and safety of the investigational agent DISC-3405.
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It will also evaluate measures of pharmacodynamic activity, including markers of iron homeostasis and erythropoiesis.
The company intends to enrol four cohorts in the single-ascending dose portion. They will initially receive DISC-3405 intravenously and will later be administered a subcutaneous dose of the therapeutic.
In addition, the multiple-ascending dose portion of the study will include two cohorts, which will receive subcutaneous DISC-3405 injections.
Disc Medicine president and CEO John Quisel said: “The initiation of this trial marks the third programme that Disc has brought into the clinic, and strengthens our position as leaders in the field of hepcidin biology and iron homeostasis.
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By GlobalData“We believe DISC-3405 has potential across a broad range of diseases where restricting iron may have therapeutic benefit, such as polycythemia vera, iron overload conditions and other diseases.
“This milestone comes at an exciting time for us, as we plan to share data updates from ongoing clinical studies of our other two programmes, bitopertin and DISC-0974, later this year.”
After the completion of this study, the company plans to start a clinical trial using DISC-3405 in polycythemia vera, for which the therapeutic received fast-track designation.
DISC-3405, earlier known as MWTX-003, targets anti-Transmembrane Serine Protease 6 (TMPRSS6) to reduce serum iron levels and increase the production of hepcidin.
The company in-licensed DISC-3405 from Mabwell Therapeutics in January this year.
