Keros Therapeutics Faces Major Setback as PAH Trial Dosing Suspended Over Safety Concerns

Dosing Suspension:
Keros Therapeutics has voluntarily suspended dosing in two treatment arms of its Phase II TROPOS trial for cibotercept (KER-012), a candidate therapy for pulmonary arterial hypertension (PAH), due to safety concerns23.

Safety Concerns:
The suspension was prompted by reports of fluid buildups around the heart in patients participating in the trial3.

Market Impact:
Keros shares plummeted by as much as 72% in pre-market trading on Thursday, December 12, 2024, potentially wiping out nearly all gains made by the stock this year14.

Trial Details:
The Phase II TROPOS trial was evaluating cibotercept (KER-012) for the treatment of PAH, a serious lung disorder characterized by high blood pressure in the arteries that supply blood to the lungs24.

Company Response:
The company described the setback as "unanticipated" and is reviewing the data to determine the next steps for the trial4.

Sources:

1. https://www.bloomberg.com/news/articles/2024-12-12/keros-plunges-after-dosing-halted-in-lung-drug-trial-on-safety

2. https://c.firstwordpharma.com/firstwordgroup/assets/images/pahpulmonaryarterialhypertension.png?sa=X&ved=2ahUKEwi588X8qSKAxUPlokEHX--N8cQ_B16BAgGEAI

3. https://www.fiercebiotech.com/biotech/keros-halts-2-dosing-arms-hypertension-trial-over-fluid-build-ups-around-heart

4. https://www.biopharmadive.com/news/keros-halt-dosing-pulmonary-arterial-hypertension-drug-trial-winrevair/735347/