Voluntary Halt in TROPOS Trial
Keros Therapeutics, Inc. announced that it has voluntarily halted all dosing in the TROPOS trial, a Phase II clinical trial of cibotercept (KER 012) in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”), including the 1.5 mg/kg and placebo treatment arms, based on the ongoing safety review due to new observations of pericardial effusion adverse events
On December 12, 2024, the Company announced that it had voluntarily halted the 3.0 mg/kg and 4.5 mg/kg treatment based on the observation of pericardial effusions at those dose levels.
“While we are disappointed in this new development, patient safety is always our top priority. We continue to work with the investigators, the U.S. Food and Drug Administration (“FDA”) and other relevant regulatory authorities, and we look forward to analyzing and presenting TROPOS topline clinical data in the future,” said Jasbir S. Seehra, PhD., Chair and CEO.
The Company has notified investigators and certain regulatory authorities, including the FDA, about this decision, and is in the process of notifying other relevant regulatory authorities. The TROPOS trial is being terminated early, and patients are expected to be monitored through the end-of-trial visits. The Company continues to expect to present topline data from all treatment arms in this trial in the second quarter of 2025.
TROPOS (NCT05975905) is a randomized, double-blind, placebo-controlled, global Phase II clinical trial to evaluate cibotercept in combination with background therapy in patients with PAH. The primary objective of this trial is to evaluate the effect of cibotercept on pulmonary hemodynamics compared to placebo in participants on background PAH therapy. The key secondary objective of this trial is to evaluate the effect of cibotercept on exercise capacity compared to placebo on participants on background PAH therapy.
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