Keros Therapeutics Updates Phase 2 TROPOS Trial Enrollment

Keros Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Lexington, Massachusetts, has recently announced the completion of screening for its TROPOS trial. This is a Phase 2 clinical study evaluating the effects of cibotercept (KER-012) combined with background therapy in patients suffering from pulmonary arterial hypertension (PAH). The company expects to finalize enrollment by the end of September and aims to present initial data in the second quarter of 2025.

Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer of Keros, expressed satisfaction with the trial's progress, highlighting the significant demand and rapid pace of enrollment. This progress allows the company to share preliminary results sooner than initially planned, now targeting the second quarter of 2025 for data release.

Chris Rovaldi, President and Chief Operating Officer, extended gratitude to the TROPOS trial's investigators, research staff, and participating patients. He emphasized that this milestone brings Keros closer to providing a potentially unique treatment for those living with PAH.

The TROPOS trial, identified as NCT05975905, is a global Phase 2 clinical study that is randomized, double-blind, and placebo-controlled. Its primary goal is to assess how cibotercept impacts pulmonary hemodynamics in patients already receiving background PAH therapy. A key secondary aim is to determine the effect of cibotercept on exercise capacity compared to a placebo in these patients.

Cibotercept is engineered to bind and inhibit the signaling of TGF-β ligands responsible for smooth muscle hypertrophy and fibrosis, such as activin A, activin B, and myostatin. Keros believes that inhibiting these ligands can enhance bone morphogenic protein (BMP) pathway signaling, thereby addressing diseases like PAH that are associated with reduced BMP signaling due to inactivating mutations in BMP receptors. Cibotercept is also being explored as a treatment for other cardiovascular disorders.

Keros Therapeutics, Inc. is dedicated to developing and commercializing new treatments for various disorders linked to dysfunctional signaling of the TGF-ß family of proteins. These proteins are crucial regulators of the growth, repair, and maintenance of multiple tissues, including blood, bone, skeletal muscle, adipose, and heart tissue. By leveraging their deep understanding of TGF-ß protein mechanisms, Keros aims to create therapeutic proteins that provide significant, potentially disease-modifying benefits to patients.

The company's leading product candidate, elritercept (KER-050), is in development for treating low blood cell counts, or cytopenias, such as anemia and thrombocytopenia, in patients with myelodysplastic syndromes and myelofibrosis. Cibotercept, their second candidate, is being studied for PAH and other cardiovascular conditions. Keros’ third product candidate, KER-065, is in development for treating obesity and neuromuscular diseases.

Keros continues to make strides in the biopharmaceutical field, with significant progress in its clinical trials and development of novel treatments. The company's advancements in understanding and targeting the TGF-ß family of proteins hold promise for developing therapies that could offer meaningful benefits to a wide range of patients.