Shenzhen Evergreen Therapeutics Co., Ltd. announced on October 13, 2020, Beijing time, that the US FDA has officially approved its phase I Clinical Application (IND) for the treatment of idiopathic interstitial pneumonia (idiopathic interstitial pneumonia).
EG-001 is one of Evergreen's nine R&D pipelines, used to control Idiopathic Interstitial Pneumonias (IIP). IIP is a kind of rare disease with unknown etiology and similar clinical features. Histologically, IIP can be classified into 6 subclasses, characterized by various degrees of pulmonary inflammation and pulmonary fibrosis. The clinical manifestations of IIP are progressive dyspnea and pulmonary imaging abnormalities. None of the countries in the world have approved drugs to treat IIP. In the face of such an incurable disease, heavy use of glucocorticoids is the only alternative therapy available to keep patients alive. However, long-term glucocorticoid treatment is not only of uncertain efficacy, but can cause a series of side effects. Advanced IIP patients can only be saved through lung transplantation. EG-001 has highly selective immune regulation and anti-inflammatory effects. Pharmacological experiments have shown that EG-001 can selectively activate many anti-inflammatory genes, such as EnaC, but it does not activate genes that cause glucocorticoid side effects such as FKBP5. In 2017, there were about 200,000 cases of IIP worldwide, including 37,000 cases in the United States and 57,000 cases in China. The global IIP market is estimated to exceed $4 billion.
The IND of EG-001 is the second IND approval after EG-009, another selected drug that was approved for clinical use. The two were approved only 20 days apart. Evergreen Therapeutics Inc., a rapidly growing innovative pharmaceutical company, has been preparing the IND application since last year. Like with EG-009, Evergreen has made a lot of arrangements for basic research and patent application of idiopathic interstitial pneumonia while preparing for clinical trials. "IIP is a global medical problem. There is a huge gap in the clinical demand for IIP treatment," said Dr. Xin Du, CEO of Evergreen. “Focusing on clinical needs and drug value is the belief we have always held. Therefore, we will fully promote the clinical study of EG-001 and strive to provide an effective therapeutic drug for IIP patients as soon as possible. "