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Discontinues Development of Cibotercept in PAH
Announces Corporate Restructuring to Align Operations with Ongoing Strategic Priorities
LEXINGTON, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros", the "Company" or "we") (NASDAQ:KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins,today announced topline data from the TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension ("PAH"), and provided a corporate update.
TROPOS Trial Results
TROPOS is a randomized, double-blind, placebo-controlled, global Phase 2 clinical trial to evaluate cibotercept in combination with background therapy in patients with PAH. On December 12, 2024, the Company announced that it had voluntarily halted the 3.0 mg/kg and 4.5 mg/kg treatment arms based on the observation of pericardial effusions at those dose levels. Furthermore, on January 15, 2025, the Company announced that it had voluntarily halted all dosing in the trial, 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. Following the early termination of the trial, patients continued to be monitored through their end-of-trial visits.
Following the analysis of all available safety and efficacy data from the TROPOS trial, the Company has decided to discontinue all development of cibotercept in PAH.
"Additional treatment options for individuals with PAH are critically needed," said Jasbir S. Seehra, Ph.D, Chair and Chief Executive Officer. "We are immensely grateful to the patients, investigators and Keros colleagues for their dedication to seeking new treatment options for this devastating disease."
The Company shared top-line results in a presentation that will be accessible in the Investors section of the Keros website at https://ir.kerostx.com. The Company plans to submit more detailed findings from the TROPOS trial at a future medical meeting.
The Company plans to further evaluate the appropriate development strategy for cibotercept, if any, in other indications following the completion of the strategic alternative review process.
Posted In: KROS
