Press release
Keros Therapeutics Announces Preliminary Results from its Phase 2 Clinical Trial Evaluating KER-050 in Patients with Myelodysplastic Syndromes
LEXINGTON, Mass., June 22, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on
About this update from Keros Therapeutics, Inc.
[{"type":"text","content":"LEXINGTON, Mass., June 22, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, today announced preliminary results from Cohorts 1 and 2 of its Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (“MDS”) who either have ring sideroblasts (“RS positive”) or do not have ring sideroblasts (“non-RS”) and who either have or have not previously received treatment with an erythroid stimulating agent. The ongoing trial is designed as an open-label, two-part, multiple ascending dose trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of KER-050 in patients with MDS. As of May 14, 2021 (the “data cut-off date”), 12 patients had received at least one dose of KER-050, nine of whom had completed eight weeks of treatment. Patients in Cohort 1 and 2 received 0.75 mg/kg and 1.5 mg/kg doses of KER-050, respectively, once every four weeks for 12 weeks. Preliminary results from Cohorts 1 and 2 of the trial, as of the data cut-off date, include: Five patients that completed eight weeks of treatment with KER-050 as of the data cut-off date met at least one of the following endpoints: Increase in hemoglobin ≥ 1.5 g/dL for eight weeks, or50% reduction in transfusion requirements over eight weeks, orTransfusion independence for at least eight weeks. Observed increases in reticulocytes, hemoglobin and platelets.Observed clinically meaningful reductions in transfusion burden in both RS positive and non-RS patients that required transfusions at baseline (≥2 red blood cell units over eight weeks).Three patients that completed eight weeks of treatment with KER-050 as of the data cut-off date achieved transfusion independence for at least eight weeks. As of the data cut-off date, KER-050 was well tolerated in Cohorts 1 and 2 of this trial. No drug-related serious adverse events (“SAEs”) were reported. There were four treatment-emergent SAEs reported, all of which were deemed unrelated to study drug, including anemia, febrile illness, pneumonia and death. Two patients wi...