Keros Therapeutics Inc. (KROS) is poised to release updates from its Phase II trials of Elritercept, a lead drug candidate targeting ineffective hematopoiesis in myelodysplastic syndromes (MDS) and myelofibrosis (MF), in the fourth quarter of 2024. These updates are keenly anticipated, as previous data have suggested the potential for Elritercept to address critical unmet needs in these challenging hematological disorders.
Elritercept in Myelodysplastic Syndromes
Myelodysplastic syndromes represent a group of bone marrow disorders characterized by ineffective hematopoiesis, leading to peripheral cytopenias. In the United States, MDS affects an estimated 60,000 to 170,000 individuals, with 15,000 to 20,000 new cases diagnosed annually. Current treatment options for anemia in lower-risk MDS include RBC transfusions, erythroid stimulating agents, Reblozyl, and RYTELO. Elritercept aims to improve red blood cell and platelet production by acting across the spectrum of cellular differentiation and maturation in hematopoiesis.
In the ongoing two-part Phase II trial, Elritercept has demonstrated durable transfusion independence in lower-risk MDS patients, including those with high transfusion burden. Updated results presented in June highlighted associations between durable clinical responses and improvements in patient-reported fatigue. Additional data from Part 2 of this trial are expected in the fourth quarter of 2024, offering further insights into Elritercept's efficacy and safety profile.
Elritercept in Myelofibrosis
Myelofibrosis is a rare bone marrow cancer characterized by the replacement of marrow with scar tissue, impairing healthy blood cell production. Approximately 16,000 to 18,500 individuals in the United States live with MF, with about 3,000 new diagnoses each year. Approved drugs for MF include Inrebic, Vonjo, and Jakafi. Elritercept is being evaluated as a monotherapy and in combination with Jakafi in a Phase II trial.
Findings reported in June indicated that Elritercept not only improves ineffective hematopoiesis and alleviates cytopenias but also provides broader clinical benefits, including significant reductions in spleen volume and enhancements in total symptom scores. These findings suggest a potential for Elritercept to address multiple facets of MF, offering a more comprehensive treatment approach. Additional data from this trial are also expected in the fourth quarter of 2024.
Other Pipeline Developments
Keros Therapeutics is also advancing other investigational drugs. Cibotercept, in combination with background therapy, is currently in a Phase II trial (TROPOS) for pulmonary arterial hypertension, with enrollment expected to complete this quarter. KER-065, being developed for obesity and neuromuscular disorders, is in a Phase I trial in healthy volunteers, with data anticipated in the first quarter of 2025.
Financial Position
As of June 30, 2024, Keros Therapeutics reported cash and cash equivalents of $405.9 million, providing a solid financial foundation for ongoing and planned clinical trials.
