Investing.com -- Shares of Keros Therapeutics (NASDAQ:KROS) tumbled 17% after the company announced a voluntary halt on all dosing in the TROPOS trial, which is evaluating cibotercept (KER-012) in patients with pulmonary arterial hypertension (PAH). The decision came as a result of new safety concerns related to pericardial effusion adverse events.
The clinical-stage biopharmaceutical company, specializing in treatments for disorders linked to dysfunctional signaling of the TGF-ß protein family, had previously suspended the 3.0 mg/kg and 4.5 mg/kg treatment arms on December 12, 2024, due to similar observations. The recent expansion of the halt to include the 1.5 mg/kg and placebo groups underscores the severity of the safety issues encountered.
Keros Therapeutics' CEO, Jasbir S. Seehra, PhD., expressed disappointment over the development but emphasized that patient safety remains the company's top priority. The firm is collaborating with investigators, the FDA, and other regulatory bodies as it plans to analyze and eventually share the TROPOS trial's topline clinical data.
The company has informed investigators and regulatory authorities, including the FDA, about the halt and is in the process of notifying other relevant agencies. With the early termination of the TROPOS trial, patients are expected to undergo end-of-trial visits. Despite the setback, Keros Therapeutics anticipates presenting topline data from all treatment arms of the trial in the second quarter of 2025.
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