===Keros Therapeutics (KROS) : drug study halted over safety concerns

 

Keros Therapeutics announces update on the phase 2 tropos trial

• Co announced that it 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 (KER-012) 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.
• 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 decision to halt the dosing in 3.0 mg/kg and 4.5 mg/kg treatment arms and continue dosing in the 1.5 mg/kg treatment arm was made in consultation with the independent DMC for the trial.