Keros Therapeutics halts dosing in trial after adverse events

Keros Therapeutics, Inc. (NASDAQ:KROS), a clinical-stage biopharmaceutical company, saw a significant drop in its stock value following the announcement that it has voluntarily paused dosing in certain arms of its Phase 2 TROPOS Trial. The decision came after a safety review identified unexpected cases of pericardial effusion, a condition where excess fluid accumulates around the heart, among participants in the trial.

The TROPOS trial, which is currently fully enrolled, is evaluating the safety and efficacy of cibotercept (KER-012) in combination with standard therapy for patients with pulmonary arterial hypertension (PAH). The adverse events prompted the company to stop dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms. However, dosing at the 1.5 mg/kg level is continuing, as a risk and benefit assessment by the independent Data Monitoring Committee (DMC) and a select group of unblinded individuals at Keros supported its ongoing administration.

Jasbir S. Seehra, Ph.D., Chair and CEO of Keros, emphasized the company's commitment to patient safety, stating, "We are working diligently to gain a better understanding of these unanticipated findings." He also confirmed that Keros is actively collaborating with the trial investigators, the U.S. Food and Drug Administration (FDA), and other regulatory authorities to resolve the issue swiftly.

While dosing has been halted for the higher treatment arms, Keros will continue to collect safety and efficacy data for all groups involved in the trial. The company has informed the trial investigators and the FDA of the halt in dosing and is in the process of notifying other pertinent regulatory bodies. Keros anticipates presenting topline data from all treatment arms of the TROPOS trial in the second quarter of 2025 and will provide additional information when there are significant developments.

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Source: Investing.com