LEXINGTON, Mass. - Keros Therapeutics, Inc. (NASDAQ: KROS), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration has awarded Fast Track designation to its lead product candidate, KER-050 (elritercept), for treating anemia in adults with certain risk levels of myelodysplastic syndromes (MDS).
The Fast Track designation is intended to hasten the development and review of drugs that show potential to meet unmet medical needs in serious or life-threatening conditions. This designation will allow Keros Therapeutics more frequent interactions with the FDA to discuss KER-050's development plan and enables a rolling submission of the marketing application. It may also lead to priority review and accelerated approval.
KER-050 is designed to treat cytopenias, including anemia and thrombocytopenia, in patients with MDS and myelofibrosis. It is a fusion protein that combines a modified ligand-binding domain of the TGF-β receptor with a fragment of the human antibody, aiming to address dysfunctional signaling of the TGF-β family of proteins.
Jasbir S. Seehra, Ph.D., President and CEO of Keros, expressed the company's commitment to fulfilling the urgent need for new treatments for lower-risk MDS. The company plans to initiate a Phase 3 clinical trial for KER-050 in the first half of this year.
Keros Therapeutics is focused on developing treatments for a variety of disorders linked to TGF-β protein signaling, including blood, bone, and heart tissue growth, repair, and maintenance. Besides KER-050, the company's pipeline includes KER-012 for pulmonary arterial hypertension and cardiovascular disorders, and KER-065 for obesity and neuromuscular diseases.
The information in this article is based on a press release statement from Keros Therapeutics, Inc. The company's forward-looking statements involve risks and uncertainties, including the need for additional funding, dependence on product candidate success, and potential delays in clinical trials. These risks are detailed in the company's SEC filings.
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