Keros Therapeutics provides update on Phase 2 TROPOS trial

Keros Therapeutics (KROS) has voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms in the ongoing TROPOS trial, a Phase 2 clinical trial of cibotercept in combination with background therapy in patients with pulmonary arterial hypertension, based on a safety review due to the unanticipated observation of pericardial effusion adverse events in the trial. “We are working diligently to gain a better understanding of these unanticipated findings,” said Jasbir Seehra, CEO. “Above all, patient safety is our top priority when conducting any clinical trial. We will work with the investigators, the FDA and other relevant regulatory authorities to address this as quickly as possible.” The TROPOS trial is fully enrolled, and dosing in the 1.5 mg/kg treatment arm remains ongoing following completion of a risk and benefit assessment of the data from the ongoing trial that was conducted by the independent Data Monitoring Committee followed by a select group of unblinded individuals at Keros. The company intends to continue ongoing safety and efficacy data collection for all treatment arms in the trial and continues to expect to present topline data from all treatment arms in this trial in Q2 of 2025. The company expects to provide additional information when there is a material update.