Keros Therapeutics, Inc. announced on December 12, 2024, that it has voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of its ongoing Phase 2 TROPOS trial for cibotercept. This decision was made following a safety review that revealed unanticipated pericardial effusion adverse events in patients receiving these higher doses.
The TROPOS trial is evaluating cibotercept in combination with background therapy for patients with pulmonary arterial hypertension (PAH). While dosing in the higher dose arms has been stopped, the 1.5 mg/kg treatment arm remains ongoing after a risk and benefit assessment by an independent Data Monitoring Committee.
Keros is working to understand these findings and has notified regulatory authorities, including the U.S. Food and Drug Administration. The company still expects to present topline data from all treatment arms in this trial during the second quarter of 2025.
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