WATERTOWN, MA, USA I October 03, 2023 I 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 the initiation of a Phase 1 study of DISC-3405 (formerly MWTX-003) in healthy volunteers. DISC-3405 is a monoclonal antibody designed to target TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) to increase hepcidin and decrease iron.

“The initiation of this trial marks the third program that Disc has brought into the clinic and strengthens our position as leaders in the field of hepcidin biology and iron homeostasis. 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. We look forward to pursuing those indications upon the completion of this trial,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “This milestone comes at an exciting time for us, as we plan to share data updates from ongoing clinical studies of our other two programs, bitopertin and DISC-0974, later this year.”

The study will be a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1 trial in healthy volunteers and will evaluate safety, tolerability, pharmacokinetics, and measures of pharmacodynamic activity, including markers of iron homeostasis and erythropoiesis. The single-ascending dose portion of the study is planned to enroll four cohorts at increasing dose levels, starting with intravenous administration with a plan to move to subcutaneous administration later in the study. The multiple-ascending dose portion is planned to enroll two cohorts, each receiving subcutaneous injections of DISC-3405. Following completion of this study, Disc plans to initiate a trial in polycythemia vera, for which DISC-3405 has received Fast Track Designation.

About DISC-3405 (previously MWTX-003)

DISC-3405, formerly known as MWTX-003, is an investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody designed to increase hepcidin production and suppress serum iron, that Disc in-licensed from Mabwell Therapeutics in January 2023. Preclinical studies of DISC-3405 have demonstrated an increase in hepcidin production and suppression of serum iron levels in animal models of beta-thalassemia and polycythemia vera. Disc plans to develop DISC-3405 initially as a treatment for polycythemia vera as well as other iron-overload conditions.

DISC-3405 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide.

About Disc Medicine

Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit www.discmedicine.com.

SOURCE: Disc Medicine