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Third IND of Evergreen Therapeutics Inc. Was Successfully Approved by the FDA within One Month
Source:Egpharm Date: Oct,2020 Views: 242

On October 27, 2020 (Beijing time), Shenzhen Evergreen Therapeutics Co., Ltd. announced that the US FDA had approved its application for the phase II clinical trial of COVID-19 EG-009A in advance on October 26, Eastern Time. The IND application was made under the FDA's CTAP* program specific to the Novel Coronavirus Pneumonia. The entire IND review took only 29 natural days.


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EG-009A is one of the nine R&D pipelines of Evergreen. It is mainly used for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe patients with the new COVID-19. This approval marks Evergreen's position as the only global innovator to have both oral and injectable agents for COVID-19, and its full coverage of the cytokine storm caused by the COVID-19 virus. On September 23, 2020, Evergreen received FDA approval for an IND, an oral capsule EG009, to prevent and treat novel Coronavirus-induced mild or moderate cytokine storms. Different from EG009, the approved injectable drug EG009A is mainly used to treat moderate/severe cytokine storms caused by the novel Coronavirus. According to the different stages of patients' disease, Evergreen provides different ways of drug administration, striving to ensure the maximum bioavailability of the drug after entering the human body while ensuring its efficacy.

 

According to epidemiologists, COVID-19 is now the biggest infectious disease threatening the lives of all people. By June 2021, there will be 250 million COVID-19 infections and 1.75 million deaths globally. Cytokine storms are one of the leading causes of death in COVID-19 patients, and the various antiviral drugs currently under development do not have the same anti-CRS effect. CRS is a complex inflammatory response. During the occurrence of CRS, a large number of cytokines are produced in body fluids, causing acute respiratory distress syndrome and multi-organ failure. In addition, some patients may experience a second cytokine storm after discharge from the hospital. EG-009 and EG-009A can inhibit the activity of various cytokines, thus having the ability to treat moderate and severe COVID-19. Evergreen began developing COVID-19 treatments immediately after the COVID-19 outbreak, extensively researching and filing patents for its COVID-19 treatment line while preparing for clinical trials. Phase I clinical trials of EG-009 oral drug began in the United States through a large international CRO in mid-November 2020. Phase II clinical trials of Evergreen EG-009A are expected to begin shortly.

 

"The approval of EG009A IND is an important milestone in Evergreen 's development," said Dr. Xin Du, CEO of Evergreen Therapeutics. "Within a month, Evergreen filed three IND applications, and three IND applications were approved by the FDA either in advance or on time. This is great support and encouragement for an innovative pharmaceutical enterprise in rapid development, and it is also a reflection of Evergreen 's well-accumulated development and rational distribution of pipelines. Evergreen will continue to closely monitor urgent clinical needs to further accelerate the optimization of clinical trials and other pipelines. It should be noted that although several COVID-19 drugs are under development worldwide, Evergreen is the only innovative pharmaceutical company in the world that has both oral and injectable preparations to treat cytokine storms caused by the novel Coronavirus. We appreciate the trust placed in us by the FDA and the investors. We are racing against the clock to make an effective treatment for COVID-19 patients available."