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Shenzhen Evergreen Therapeutics' COVID-19 Drug EG-009A has been approved for phase II clinical trials in India
Source:Egpharm Date: Sep,2021 Views: 702

Shenzhen Evergreen Therapeutics Co., Ltd. (hereinafter referred to as "Evergreen Therapeutics" or "Evergreen") announced on September 14, 2021 that DCGI, the Indian regulatory authority, has officially approved the phase II clinical trial of EG-009A for COVID-19 in India.

EG-009A is one of Evergreen's 13 R&D pipelines and will be used to treat Cytokine Release Syndrome (CRS) caused by COVID-19 infections. India is one of the major regions where the Delta variant of COVID-19 is prevalent, and the phase II clinical trial was approved to understand the efficacy of EG-009A in patients with moderate to severe COVID-19 caused by the Delta variant. It is understood that this is the world's first clinical trial with COVID-19 Delta variant as the main research target, so it has a great clinical significance.

According to statistics from the World Health Organization (WHO), as of September 2021, the number of COVID-19 infections worldwide had reached about 230 million, with more than 4.6 million deaths. In India, the number of COVID-19 infections has exceeded 33 million, with 440,000 deaths. In July 2021, WHO announced that the Delta Variant (B.1.617.2) had spread to 132 countries and regions, especially in the United Kingdom and India. About 90% of new confirmed cases in the UK and India have been caused by the Delta strain.

Dr. David Du, CEO of Evergreen Therapeutics pointed out:


"The FDA has approved our company to conduct a phase II clinical trial of EG-009A for moderate-to-severe COVID-19 in the U.S. This is an international multicenter clinical trial that will be expanded to include Brazil and Argentina. The phase II trial approved in India is our first outside of the Americas. We thank DCGI, India's medical regulator, for their support during the review process.

COVID-19 is the disease that poses the greatest threat to humanity today, and the recurrent mutation of COVID-19 will render some of the existing vaccines ineffective. The occurrence of cytokine storm is closely related to the mortality rate of patients with COVID-19. According to clinical data published by Imperial College London, the mortality rate of patients with COVID-19 who were at high risk of cytokine storm at admission was as high as 55.9% (Vizcaychipi, et al, Braz J Infect Dis. 2020; 24:42:421), therefore, inhibition of cytokine storms caused by COVID-19 is an important means for the treatment of moderate to severe COVID-19 and the reduction of mortality in PATIENTS with COVID-19.

EG-009A is a highly selective glucocorticoid receptor modulator. Preclinical pharmacologic studies have shown clear efficacy against cytokine storms induced by COVID-19. To address moderate-to-severe COVID-19 caused by different viral variants, we will conduct clinical trials in multiple locations around the world.

This trial is our first clinical trial in India, and we will work closely with the CRO team in India to conduct and successfully complete this trial as soon as possible. In the coming months, our clinical trials will expand to other countries, providing a solid data base for the efficacy and broad spectrum of EG-009A products."

About Evergreen Therapeutics:

Evergreen Therapeutics is a rapidly growing international biomedical company in the clinical stage, committed to the discovery and development of innovative drugs, as well as clinical research and commercialization worldwide. The company's mission is to "focus on clinical needs and achieve medical value", focusing on the development of innovative drugs in the fields of autoimmunity, tumor immunity, and chronic diseases.

Adhering to the development strategy of globalization and differentiation, Evergreen actively carried out the development of new targets and new indications of existing drugs while exploring new molecules. Drug Repurposing not only reduced the research cost and accelerated the speed of research and development, but also improved the probability of success and the value of the drug.

Today, with a long development cycle and high cost of new drugs, Drug Repurposing is becoming a trend of new drug development. Evergreen believes in the corporate value of "paying attention to clinical needs and realizing medical value"; The enterprise development concept of "abandon the focus on homogenization and focus on differentiated R&D" and the development strategy of "with global vision and focus on drug value" will continue to lead the future trend of the pharmaceutical industry.