Keros Therapeutics, Inc. announced on January 15, 2025, that it has voluntarily halted all dosing in its Phase 2 TROPOS trial for cibotercept, including the 1.5 mg/kg and placebo treatment arms. This decision follows new observations of pericardial effusion adverse events during an ongoing safety review.
The TROPOS trial, which was evaluating cibotercept for pulmonary arterial hypertension (PAH), is being terminated early. Patients who were enrolled in the trial are expected to be monitored through their end-of-trial visits.
Keros has notified investigators and regulatory authorities, including the U.S. Food and Drug Administration, about this decision. The company still anticipates presenting topline data from all treatment arms in this trial during the second quarter of 2025, despite the early termination.
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