Biotech Values

[DewDiligence]

KROS—(-77%)—halts phase-2 dosing on safety signal:

https://finance.yahoo.com/news/keros-therapeutics-announces-phase-2-110000332.html

Keros Therapeutics…today announced that it has voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms in the ongoing TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”), based on a safety review due to the unanticipated observation of pericardial effusion adverse events in the trial.

The TROPOS trial is fully enrolled, and dosing in the 1.5 mg/kg treatment arm remains ongoing following completion of a risk and benefit assessment of the data from the ongoing trial that was conducted by the independent Data Monitoring Committee (“DMC”) followed by a select group of unblinded individuals at Keros. The decision to halt the dosing in 3.0 mg/kg and 4.5 mg/kg treatment arms and continue dosing in the 1.5 mg/kg treatment arm was made in consultation with the independent DMC for the trial. The Company intends to continue ongoing safety and efficacy data collection for all treatment arms in the trial.

Pericardial effusion (fluid in the pericardium) can be mild or serious, but KROS needs to understand why it is happening at all.