VASTHERA Receives FDA Clearance for Phase 1 Trial of Novel PAH Drug VTB-10

Key Insights

• VASTHERA received FDA IND clearance on August 6, 2025, to initiate Phase 1 clinical trials for VTB-10, a first-in-class drug candidate targeting pulmonary arterial hypertension.
• VTB-10 is developed using VASTHERA's proprietary Redoxizyme™ platform and functions as a small molecule enzyme that replicates peroxiredoxin function to address enzyme deficiency in PAH lesions.
• Preclinical studies demonstrated VTB-10's ability to reverse abnormal vascular remodeling and restore functional endothelium, differentiating it from existing PAH therapies.

VASTHERA Co., Ltd. announced on August 6, 2025, that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration to initiate a Phase 1 clinical trial for VTB-10, its drug candidate for pulmonary arterial hypertension (PAH). PAH is described as a rare, life-threatening disease characterized by elevated blood pressure in the lung arteries.

Novel Mechanism of Action

VTB-10 represents a first-in-class drug candidate developed using VASTHERA's proprietary Redoxizyme™ platform. The company identified a deficiency of the enzyme peroxiredoxin (PRX) in PAH lesions and developed VTB-10 as a small molecule enzyme, termed a "Chemzyme," that precisely replicates PRX function.

In preclinical studies, VTB-10 demonstrated the ability to reverse abnormal vascular remodeling and restore functional endothelium. According to VASTHERA, these dual effects clearly differentiate the drug candidate from existing therapies for PAH.

Regulatory Milestones and Support

The FDA clearance follows the agency's designation of VTB-10 as an Orphan Drug in November 2024, which enabled VASTHERA to formally begin global clinical development. The development program has received support through national funding from the Korea Drug Development Fund (KDDF).

"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," stated Dr. Sang Wong Kang, Ph.D., CEO of VASTHERA. "Through upcoming clinical trials, we aim to deliver an innovative treatment that can significantly improve quality of life for PAH patients."

Platform Technology and Pipeline Potential

Dr. Sang Wong Kang, who has expertise in redox regulation of cellular signaling from his early research at the NIH/NHLBI, has dedicated more than two decades to building the scientific foundation of the Redoxizyme™ platform. Since PRX deficiency is implicated in multiple diseases, the platform holds broad potential for developing novel therapeutics across various indications, supporting sustainable growth and long-term value creation in the global market.

VASTHERA is building its Redoxizyme™-based pipeline with VTB-10 as the cornerstone. The initiation of the Phase 1 clinical study represents a significant step in the evolution of VASTHERA's pipeline portfolio with global potential.