Keros Therapeutics initiated Phase 3 trials for elritercept, a treatment for transfusion-dependent anemia in patients with myelodysplastic syndromes (MDS). This milestone triggers a $10 million payment from Takeda Pharmaceutical Company as part of a previously established licensing agreement. The RENEW trial will assess elritercept’s effectiveness in reducing the need for red blood cell transfusions in MDS patients.
This Phase 3 trial initiation is crucial for advancing a potential new therapy for MDS-related anemia. Current treatment options often fall short, highlighting the urgent need for more effective therapies that improve patients’ quality of life by lessening their dependence on transfusions. The successful development of elritercept could significantly alter the treatment landscape for individuals with this condition.
The commencement of this trial follows a licensing agreement between Keros and Takeda finalized in January 2025. This agreement included a $200 million upfront payment to Keros, with potential future milestone payments exceeding $1.1 billion, plus royalties on net sales. Elritercept functions by trapping specific TGF-ß proteins, which are implicated in the dysfunctional cell signaling that leads to blood cell deficiencies in conditions like MDS.
This Phase 3 trial represents a substantial step toward potentially bringing a much-needed therapy to market for patients with MDS. Positive trial results could lead to regulatory approval and subsequent commercialization, offering a new treatment avenue and potentially generating significant revenue for both Keros and Takeda. The outcome of this trial will be highly anticipated by clinicians, patients, and the pharmaceutical industry.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
