GNT Pharma Applies for Phase 1 Clinical Trial of Asthma New Drug 'Flusalazine'

GNT Pharma announced on the 3rd that it has submitted the clinical trial application (IND) for Phase 1 clinical trials of ‘Flusalazine,’ a next-generation treatment for inflammatory and respiratory diseases, to the Ministry of Food and Drug Safety.

GNT Pharma's inflammation and pain treatment 'Flusalazine'
[Photo by GNT Pharma]

This clinical trial will be conducted in two parts to study the safety, tolerability, and pharmacokinetics of oral administration of Flusalazine in healthy adults. In Part 1, the safety, absorption, distribution, metabolism, and excretion of Flusalazine will be studied after a single dose with increasing amounts under fasting or fed conditions. In Part 2, safety and pharmacokinetics will be explored after repeated administration of Flusalazine twice daily for a total of 15 doses.

Flusalazine is being developed as a next-generation anti-inflammatory drug that improves gastrointestinal side effects of non-steroidal anti-inflammatory drugs (NSAIDs). It is described as a multi-target new drug with strong antioxidant and tissue-protective effects. It demonstrated inflammation regulation and tissue protection effects in animal models of chronic obstructive pulmonary disease (COPD) and asthma, and a new international patent was filed last year.

COPD and asthma are intractable diseases, with COPD in particular characterized by chronic inflammation in the bronchi and lung parenchyma caused by cigarette smoke, occupational exposure to harmful gases, and lung infections, leading to airway narrowing and lung destruction. It is known that there are approximately 500 million patients worldwide with COPD and asthma. Anti-inflammatory drugs such as corticosteroids, and bronchodilators such as beta-2 agonists and anticholinergics are used for symptoms like cough and breathing difficulties, but they only alleviate symptoms, making the development of new drugs urgent.

Byung-Joo Kwak, CEO of GNT Pharma (also an adjunct professor in the Department of Life Sciences at Yonsei University), said, “Excellent safety was verified in non-clinical trials, and with the patent application for the primary target diseases COPD and asthma completed, we have applied for the Phase 1 clinical trial IND for Flusalazine. Because it shows superior safety and efficacy compared to comparator drugs in animal models, good results are expected in clinical trials.”