Keros Therapeutics, Inc. presented additional data from its two ongoing phase 2 clinical trials of elritercept (ker-050) at the 29th annual hybrid congress of the European Hematology Association. In the trial for patients with lower-risk myelodysplastic syndromes (MDS), 55.6% of patients achieved an overall erythroid response over the first 24 weeks of treatment. Additionally, 41.3% of patients achieved transfusion independence for at least eight weeks over the first 24 weeks of treatment, with 61.5% of those patients maintaining transfusion independence as of the data cut-off date. Furthermore, patients who achieved transfusion independence reported clinically meaningful improvements in self-reported fatigue.
In the trial for patients with myelofibrosis (MF), increases in hemoglobin were observed in the majority of evaluable non-transfusion dependent patients, suggesting elritercept's potential to address anemia due to MF and ruxolitinib-associated anemia. Additionally, 60.6% of patients who had received at least three red blood cell units per 12 weeks at baseline showed reductions in transfusion burden over 12 weeks within the first 24 weeks. Furthermore, some reduction in spleen volume was observed in 52.9% of patients with baseline spleen size ≥ 450 cm3, and a reduction in disease symptoms was observed in a majority of patients with at least two symptoms at baseline.
The company plans to initiate a registrational phase 3 clinical trial in MDS following positive feedback from the U.S. Food and Drug Administration. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders linked to dysfunctional signaling of the transforming growth factor-beta family of proteins. The market has reacted to these announcements by moving the company's shares -10.9% to a price of $43.99. If you want to know more, read the company's complete 8-K report here.