Evergreen Therapeutics Announces DCGI Approval for Phase II Clinical Trial of EG-009A in India for Treatment of Moderate to Severe COVID-19

Evergreen Therapeutics (hereinafter referred to as "Evergreen Therapeutics") announced on September 14, 2021, Eastern Time, that India's drug regulatory authority, the Drugs Controller General of India (DCGI), has officially approved the Phase II clinical trial in India for its injectable drug EG-009A for the treatment of COVID-19 pneumonia.

EG-009A is one of the thirteen drug candidates in Evergreen Therapeutics’ R&D pipeline and is intended for the treatment of cytokine release syndrome (CRS) induced by SARS-CoV-2 infection. As India is one of the regions most severely affected by the SARS-CoV-2 Delta variant, the newly approved Phase II clinical trial is primarily designed to evaluate the efficacy of EG-009A in patients with moderate to severe COVID-19 caused by this variant. According to available information, this marks the world’s first clinical trial specifically targeting Delta variant-associated COVID-19, thereby holding significant clinical importance.

According to statistical data from the World Health Organization (WHO), as of September 2021, global COVID-19 infections had reached approximately 230 million, with over 4.6 million deaths. In India, the number of infections exceeded 33 million, with 440,000 fatalities. In July 2021, the WHO reported that the Delta variant (B.1.617.2) had spread to 132 countries and territories, with particularly severe outbreaks in the United Kingdom and India. In both countries, approximately 90% of newly confirmed cases were attributed to the Delta variant.

Dr. Xin Du, CEO of Evergreen Therapeutics, stated:

“The U.S. FDA has approved our company to conduct a Phase II clinical trial of EG-009A for the treatment of moderate-to-severe COVID-19 in the United States. This is an international, multi-center clinical trial, and the trial regions will be expanded to Brazil and Argentina. The Phase II clinical trial approved in India marks our first clinical trial conducted outside the Americas. We thank the Indian drug regulatory authority, DCGI, for its support throughout the review process.”

COVID-19 is currently the disease posing the greatest threat to humanity, and the frequent mutations of the SARS-CoV-2 virus may render some existing vaccines ineffective. The occurrence of cytokine storms is closely correlated with the mortality rate of COVID-19 patients. According to clinical data published by Imperial College London, the mortality rate among the cohort of COVID-19 patients at high risk of cytokine storm upon hospital admission reached as high as 5.9% (Vizcaychipi, et al, Braz J Infect Dis. 2020;24:412-421). Therefore, suppressing the SARS-CoV-2-induced cytokine storm is a crucial therapeutic strategy for managing moderate-to-severe COVID-19 and reducing patient mortality.

EG-009A is a highly selective glucocorticoid receptor modulator. Preclinical pharmacological studies have demonstrated clear efficacy of this drug against SARS-CoV-2-induced cytokine storm. To address moderate-to-severe COVID-19 caused by various viral variants, we will conduct clinical trials at multiple sites worldwide.

“The study currently underway in India marks our first clinical trial in the country. We will collaborate closely with the Indian CRO team to promptly initiate and successfully complete this trial. In the coming months, our clinical trials will be expanded to other countries, providing a robust data foundation to support the efficacy and broad-spectrum activity of EG-009A.”

About Evergreen Therapeutics

Evergreen Therapeutics (hereinafter referred to as “Evergreen Therapeutics” or “Evergreen”) is a rapidly growing, clinical-stage international biopharmaceutical company dedicated to the discovery and development of innovative therapeutics, as well as global clinical R&D and commercialization. The Company’s mission is to “focus on clinical needs and realize pharmaceutical value,” focusing on the research and development of innovative drugs in the fields of autoimmune diseases, immuno-oncology, and chronic diseases.

Evergreen Therapeutics adheres to a globalized and differentiated development strategy. While exploring novel molecules, the company actively pursues the development of new targets and indications for existing drugs (Drug Repurposing). Drug Repurposing not only reduces research costs and accelerates R&D timelines, but also increases the probability of success and enhances drug value.

In today's landscape, characterized by the lengthy timelines and high costs of new drug development, Drug Repurposing is emerging as a key trend in pharmaceutical R&D. Evergreen Therapeutics adheres to the corporate value of "focusing on clinical needs to realize pharmaceutical value," embraces the development philosophy of "steering clear of homogenized hotspots to concentrate on differentiated R&D," and implements the development strategy of "maintaining a global vision and focusing on drug value," which will continue to lead future trends in the pharmaceutical industry.