㈜넥스트젠바이오사이언스

R&D Pipeline

NXC680

NXC680 is a novel small-molecule compound designed to treat Idiopathic Pulmonary Fibrosis (IPF) by inhibiting Autotaxin (ATX), an enzyme present in the extracellular matrix. By blocking ATX activity, NXC680 regulates abnormal physiological effects caused by excessive lysophosphatidic acid (LPA), thereby mitigating fibrosis progression.

In preclinical studies, NXC680 demonstrated significant anti-fibrotic effects and improved lung function in both bleomycin-induced IPF models and radiation-induced pneumonia and pulmonary fibrosis models following oral administration.

In January 2023, NXC680 received Orphan Drug Designation (ODD) from the U.S. FDA as a treatment for IPF. Additionally, in June 2024, it obtained IND approval for Phase 1 clinical trials from the KFDA and is currently preparing for Phase 1 clinical trials.

Indication	Idiopathic Pulmonary Fibrosis
Route of Administration	Oral
Development Status	Phase I
Mechanism of Action	Autotaxin Inhibito
Highlight	Excellent Tolerability at lower clinical doses compared to competitors Superior Anti-Fibrotic Effects and Lung Function Improvement Safe Profile with no severe toxicity concerns Showed potent efficacy with the results from bleomycin- and radiation-induced pulmonary fibrosis animal models Excellent PK/PD relationship and safety profile Significant pulmonary function recovery observed in radiation-induced pulmonary fibrosis model No significant safety issues observed in GLP toxicity studies US FDA Orphan drug designation in 2023 Phase I IND approval completed in 2024.