Keros Therapeutics Shares Elritercept Data at European Hematology Congress

Keros Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapeutics for disorders related to the transforming growth factor-beta (TGF-ß) protein family, has presented promising data from its ongoing Phase 2 clinical trials of elritercept (KER-050). The data were shared at the 29th Annual Hybrid Congress of the European Hematology Association (EHA), which took place in Madrid, Spain, and virtually.

In patients with lower-risk myelodysplastic syndromes (MDS), elritercept has been shown to provide durable transfusion independence, even in those with high transfusion burdens (HTB). The clinical benefits were also associated with improvements in self-reported fatigue measures. Another Phase 2 trial in myelofibrosis (MF) demonstrated that elritercept could improve ineffective hematopoiesis, reduce spleen volume, and enhance total symptom scores.

The MDS trial involves an open-label, two-part study assessing elritercept in patients with very low-, low-, or intermediate-risk MDS. By April 3, 2024, 87 patients had received at least one dose of elritercept, with 81 completing at least 24 weeks of treatment. In this cohort, 55.6% achieved an overall erythroid response over 24 weeks, and 41.3% of those evaluable for transfusion independence (TI) attained TI for at least eight weeks. Among patients with HTB, 34.8% achieved TI for at least eight weeks, and half of these maintained it for at least 24 weeks.

Elritercept was generally well-tolerated, with the most common side effects being diarrhea, fatigue, and dyspnea. Importantly, no patients progressed to acute myeloid leukemia. Patients who achieved TI reported significant improvements in fatigue, as measured by the FACIT-Fatigue scale, indicating potential quality of life benefits.

The Phase 2 RESTORE trial is evaluating elritercept in MF patients, both as monotherapy and in combination with ruxolitinib. The trial includes patients with anemia who were either currently on, failed, or were ineligible for ruxolitinib. Safety data for 54 patients revealed that elritercept was generally well-tolerated, with thrombocytopenia and diarrhea being the most commonly reported side effects. 

Most evaluable non-transfusion dependent patients showed increases in hemoglobin levels over 12 weeks, and 60.6% of those receiving at least three red blood cell (RBC) units per 12 weeks at baseline showed reductions in transfusion burden. In combination with ruxolitinib, 72.7% of patients experienced a reduction of 50% or greater in transfusion needs, and 45.5% achieved TI.

At 24 weeks, some reduction in spleen volume was observed in 52.9% of patients, with three experiencing reductions of 35% or greater. Additionally, a majority of patients reported symptom improvements, as measured by the MF-SAF-TSS questionnaire, with three achieving significant symptom reduction.

Elritercept's potential to address cytopenias and broader clinical benefits in MF, supported by spleen volume reduction and symptom score improvements, is promising. These results affirm elritercept's potential to improve ineffective hematopoiesis and provide clinical benefits in patients with MDS and MF.

Keros will discuss these findings further in a corporate update call and webcast, providing additional insights into their ongoing clinical trials and the company's pipeline developments.

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