Keros Therapeutics Initiates Phase 3 Trial for Elritercept, Triggering $10 Million Milestone Payment from Takeda.

Keros Therapeutics has initiated the Phase 3 RENEW clinical trial for elritercept, targeting adults with transfusion-dependent anemia associated with myelodysplastic syndromes. This trial has triggered a $10 million milestone payment to Keros under its agreement with Takeda Pharmaceutical Co Ltd (TAK). The collaboration agreement also includes potential future development, commercial, and sales milestones that could surpass $1.1 billion and tiered royalties from net sales of the drug.

Keros Therapeutics, Inc. (Nasdaq: KROS) has announced the initiation of the Phase 3 RENEW clinical trial for elritercept, targeting adults with transfusion-dependent anemia associated with myelodysplastic syndromes (MDS). The first patient was dosed on July 17, 2025, triggering a $10 million milestone payment to Keros under its agreement with Takeda Pharmaceutical Co. Ltd. (TAK) [1].

The global license agreement between Keros and Takeda, which became effective on January 16, 2025, includes potential future development, commercial, and sales milestones that could surpass $1.1 billion. Keros also stands to receive tiered royalties on net sales of the drug [2].

The elritercept Phase 3 RENEW clinical trial (NCT06499285) is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of elritercept in reducing red blood cell transfusions in adults with transfusion-dependent anemia with very low, low, and intermediate risk MDS [1].

Elritercept is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-β receptor known as activin receptor type IIA fused to the Fc domain of a human antibody. It is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with MDS and in patients with myelofibrosis [1].

Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer of Keros, stated, "The initiation of patient dosing in the RENEW trial marks an important next step in evaluating elritercept as a potentially differentiated therapy for patients with MDS. We are pleased to have achieved this milestone alongside our partner Takeda and look forward to seeing elritercept's potential further explored for patients in need" [1].

The collaboration with Takeda is a significant milestone for Keros, which focuses on developing novel therapeutics to treat disorders linked to dysfunctional signaling of the TGF-β family of proteins. Keros' lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy [1].

References:
[1] https://www.morningstar.com/news/globe-newswire/9496196/keros-therapeutics-announces-the-first-patient-dosing-in-the-phase-3-renew-clinical-trial-of-elritercept
[2] https://www.biospace.com/press-releases/keros-therapeutics-announces-the-first-patient-dosing-in-the-phase-3-renew-clinical-trial-of-elritercept