Keros Therapeutics, Inc. (KROS), a biopharmaceutical firm, announced on Thursday the voluntary suspension of dosing in the 3.0 mg/kg and 4.5 mg/kg treatment groups within its TROPOS trial. This decision followed a safety review that revealed unforeseen instances of pericardial effusion as adverse events during the trial.
The TROPOS trial, a Phase 2 clinical investigation, evaluates cibotercept (KER-012) in conjunction with existing therapies for patients suffering from pulmonary arterial hypertension (PAH). Despite the suspension in certain treatment arms, the trial is fully enrolled, and dosing continues in the 1.5 mg/kg cohort after a careful risk-benefit analysis conducted by the independent Data Monitoring Committee (DMC) and a select group of unblinded personnel at Keros.
The choice to discontinue the higher dosing cohorts while maintaining the 1.5 mg/kg arm was made in collaboration with the trial's independent DMC. The company remains committed to the ongoing collection of safety and efficacy data across all treatment arms.
Keros has communicated its decision to both the trial investigators and certain regulatory bodies, including notifying the FDA, and is in the process of updating other relevant regulatory authorities. The company projects that it will report topline results from all the treatment groups in the second quarter of 2025.
Keros is focused on thoroughly investigating and resolving the matter and plans to release further information as substantial updates become available.
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