FDA Fast Tracks MWTX-003 for Polycythemia Vera Treatment

The FDA has granted fast track designation to MWTX-003 (also DISC-3405) for the treatment of patients with polycythemia vera (PV).¹

MWTX-003 is an investigational anti-TMPRSS6 monoclonal antibody. The drug is designed to inflate hepcidin production and suppress serum iron. In preclinical studies, MWTX-003 treatment led to increased hepcidin production and suppression of serum iron levels in beta-thalassemia and polycythemia vera animal models.

Following an investigational new drug application being cleared by the FDA in November of 2022, MWTX-003 is now being investigated in a phase 1 clinical trial.

“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, JD, PhD, president and chief executive officer of Disc, in a press release. “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.”

MWTX-003 has no regulatory approval for any indication worldwide. Disc Medicine, Inc, plans to develop MWTX-003 in PV, as well as in other hematologic malignancies.

REFERENCES:

Disc Medicine receives FDA fast track designation for MWTX-003 for the treatment of polycythemia vera. News release. September 20, 2023. Accessed September 21, 2023. https://tinyurl.com/42veasur