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Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera
WATERTOWN, Mass., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery,
About this update from Disc Medicine, Inc.
[{"type":"text","content":"WATERTOWN, Mass., Sept. 20, 2023 (GLOBE NEWSWIRE) -- 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 that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to MWTX-003 for the treatment of patients with polycythemia vera (PV). “We are delighted to have received Fast Track designation for MWTX-003, which highlights the unmet need for PV patients and the potential of MWTX-003 in a disease where there are few treatment options,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “We believe MWTX-003 is uniquely positioned to address the needs of PV patients and are excited to initiate a Phase 1 trial in the coming months.” Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational drugs intended to treat serious conditions and for which nonclinical or clinical data demonstrate the potential to address unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data. About MWTX-003MWTX-003, also known as DISC-3405, 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 MWTX-003 have demonstrated an increase in hepcidin production and suppression of serum iron levels in animal models of beta-thalassemia and polycythemia vera. The IND was accepted in November 2022 and Disc plans to initiate a Phase 1 study of MWTX-003 in healthy volunteers during the second half of 2023. Disc plans to develop MWTX-003 initially as a treatment for polycythemia vera as well as other hematologic conditions. MWTX-003 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide. About Polycythemia Vera (PV) Polycythemia vera (PV) is a chroni...