Keros begins patient dosing in phase 3 RENEW trial of elritercept for MDS

Overview

Keros Therapeutics, Inc. (Keros), a clinical-stage biopharmaceutical company, announced that the first patient was dosed in the phase 3 RENEW clinical trial of elritercept in adults with transfusion-dependent anaemia with very low, low, or intermediate risk myelodysplastic syndromes (MDS). The dosing of the first patient triggers a $10 million milestone payment to Keros under the global license agreement with Takeda.

Statement from CEO: Keros

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,” said Jasbir S. Seehra, Ph.D., chair and chief executive officer of Keros. “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.”

Terms of agreement

• Under the terms of the global license agreement with Takeda to further develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau, which became effective on January 16, 2025, Keros received a $200 million upfront cash payment in February 2025, and is eligible to receive development, commercial and sales milestones with the potential to exceed $1.1 billion. 
• Keros will also be eligible to receive tiered royalties on net sales.

The elritercept phase 3 RENEW clinical trial (NCT06499285) is a global, randomized, double-blind, placebo-controlled trial in adults with transfusion-dependent anaemia with very low, low, and intermediate risk MDS. The primary objective is to evaluate the efficacy of elritercept in reducing red blood cell transfusions.

About Elritercept

• Elritercept is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain. 
• Elritercept is being developed for the treatment of low blood cell counts, or cytopenias, including anaemia and thrombocytopenia, in patients with MDS and in patients with MF.

About the biopharmaceutical company Keros

• Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signalling of the TGF-ß family of proteins. 
• Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue.

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