Keros Therapeutics Announces Update on the Phase 2 TROPOS Trial

Core Viewpoint - Keros Therapeutics has voluntarily halted dosing in certain treatment arms of the TROPOS trial due to safety concerns related to adverse events observed in patients with pulmonary arterial hypertension [1][2] Group 1: Company Actions - The company announced a halt in dosing for the 3.0 mg/kg and 4.5 mg/kg treatment arms of the TROPOS trial while continuing with the 1.5 mg/kg arm after a safety review [1][2] - Keros is collaborating with the FDA and other regulatory authorities to address the safety concerns and has notified investigators about the decision [2] - The company expects to present topline data from all treatment arms in the TROPOS trial in the second quarter of 2025 [2] Group 2: Trial Information - The TROPOS trial is a Phase 2 clinical trial evaluating the efficacy of cibotercept in patients with pulmonary arterial hypertension [4] - The primary objective of the trial is to assess the effect of cibotercept on pulmonary hemodynamics compared to placebo [4] - The trial is fully enrolled, and the independent Data Monitoring Committee conducted a risk and benefit assessment prior to the dosing halt [2] Group 3: Product Information - Cibotercept is designed to inhibit TGF-β signaling, which is linked to smooth muscle hypertrophy and fibrosis, potentially treating conditions like pulmonary arterial hypertension [5] - The drug aims to enhance BMP signaling pathways, which are often reduced in patients with certain cardiovascular disorders [5]