Keros Therapeutics Halts Higher Dose Arms in PAH Trial Due to Pericardial Effusion Concerns

Trial Update:
Keros Therapeutics has voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of its Phase 2 TROPOS trial due to unanticipated pericardial effusion adverse events134.

Continued Dosing:
The 1.5 mg/kg treatment arm continues following a risk-benefit assessment by the independent Data Monitoring Committee and Keros team134.

Trial Status:
The TROPOS trial is fully enrolled, and the company expects to present topline data from all treatment arms in the second quarter of 2025134.

Regulatory Notification:
The FDA and other regulatory authorities have been notified of these developments134.

Pericardial Effusion Concerns:
Pericardial effusion in PAH patients is associated with higher right atrial pressure and a worse prognosis, including increased mortality5.

Cibotercept (KER-012):
The drug is designed to inhibit the signaling of TGF-β ligands that stimulate smooth muscle hypertrophy and fibrosis, including activin A, activin B, and myostatin14.

Sources:

1. https://www.globenewswire.com/news-release/2024/12/12/2995999/0/en/Keros-Therapeutics-Announces-Update-on-the-Phase-2-TROPOS-Trial.html

3. https://www.stocktitan.net/news/KROS/keros-therapeutics-announces-update-on-the-phase-2-tropos-5cvgqz1wtblr.html

4. https://ir.kerostx.com/news-releases/news-release-details/keros-therapeutics-announces-update-phase-2-tropos-trial

5. https://meridian.allenpress.com/aph/article/15/4/198/54189/PH-Grand-Rounds-When-Pulmonary-Arterial