FDA clears new trial of first-in-class treatment for pulmonary arterial hypertension
Vasthera, a South Korean pharmaceutical company, has received U.S. Food and Drug Administration (FDA) clearance of a new clinical trial focused on the safety and effectiveness of its new drug candidate for pulmonary arterial hypertension (PAH).
Vasthera developed the drug, VTB-10, after identifying a deficiency of the enzyme peroxiredoxin (PRX) in PAH lesions. VTB-10 replicates the function of PRX, and early data suggests it can reverse abnormal vascular remodeling and restore functional endothelium. The company used its own Redoxizyme platform to develop VTB-10 from the ground up.
The FDA previously awarded VTB-10 its orphan drug designation in November 2024, highlighting the fact that the agency is prioritizing the development of new PAH treatments.
“The U.S. clinical entry of VTB-10 marks a major milestone, demonstrating Vasthera’s technological competitiveness in PAH treatment and reinforcing the global credibility of Korean biotech ventures,” Sang Wong Kang, PhD, CEO of Vasthera, said in a statement. “Through upcoming clinical trials, we aim to deliver an innovative treatment that can significantly improve quality of life for PAH patients.”
The company hopes to develop a full arsenal of Redoxizyme-developed drugs, and it believes VTB-10 will serve as the cornerstone of that plan.
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