Naivek Develops New Drug for Pulmonary Arterial Hypertension Treatment

"World's First Regenerative Mechanism, Global Clinical Advancement"

Naivek announced on the 28th that it has confirmed the excellent efficacy of its self-developed new drug substance ‘NP-201’ in treating pulmonary arterial hypertension (PAH) through preclinical experiments. Naivek plans to add pulmonary arterial hypertension as an indication in the global clinical trials of NP-201.

Recently, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s ‘Opsinvi’ as the world’s first treatment for pulmonary arterial hypertension. Following this, Merck & Company’s (Merck) new drug ‘Winrybear’ also received FDA approval, drawing attention to companies developing treatments for pulmonary arterial hypertension in the market.

NP-201 is a peptide-based therapeutic with a novel mechanism possessing regenerative functions. When NP-201 was administered to animals induced with pulmonary arterial hypertension using monocrotaline, it showed a dose-dependent effect in reducing systolic blood pressure, diastolic blood pressure, and mean blood pressure. Notably, the vascular thickness in animals with induced pulmonary arterial hypertension returned to normal, confirming the regenerative mechanism.

Pulmonary arterial hypertension is a type of pulmonary hypertension where the walls of the arteries leading from the right side of the heart to the lungs thicken, narrowing the blood vessels. Increased pressure in the lungs leads to symptoms such as fatigue and shortness of breath. In the United States, it is estimated that there are about 40,000 patients with pulmonary arterial hypertension, with 500 to 1,000 new cases occurring annually. It predominantly affects women, mostly in middle age, and is a difficult-to-treat disease with half of the patients dying within five years after diagnosis.

The treatments approved by Merck and Johnson & Johnson work by inhibiting endothelial cell receptors in blood vessels. While they improve symptoms of vessel narrowing, they have limitations in reversing vascular wall thickening and fibrosis. In contrast, Naivek explains that NP-201 can fundamentally treat the condition by inhibiting the progression of vascular wall fibrosis and restoring vascular thickness to normal.

A Naivek representative stated, “NP-201 has a mechanism effective in regeneration and remodeling, differentiating it from existing symptom-suppressing drugs,” and added, “The safety of NP-201 was also verified through global Phase 1 clinical trials last year for the treatment of pulmonary fibrosis.”

He continued, “Recently, we expanded the indication to inflammatory bowel disease and completed the Pre-IND with the U.S. FDA to proceed with clinical trials, accelerating global clinical development,” adding, “Since preclinical studies have proven NP-201’s efficacy in pulmonary arterial hypertension as well, there should be no problem in expanding its indications.”