Eglin Pharma Achieves Third FDA IND Approval Within a Month for EG-009A, Advancing Its Dual Oral and Injectable Pipeline Against COVID-19 Cytokine Storm

On October 27, 2020 (Beijing Time), Evergreen Therapeutics announced that the U.S. FDA had granted early approval on October 26 (Eastern Time) for the Phase II clinical trial application of its injectable drug EG-009A for the treatment of COVID-19. The Investigational New Drug (IND) application was reviewed under the FDA’s Coronavirus Treatment Acceleration Program (CTAP*), established specifically for COVID-19 therapies. The entire IND review process took only 29 calendar days.

EG-009A is one of the top ten R&D pipeline candidates of Evergreen Therapeutics and is primarily indicated for the treatment of cytokine release syndrome (CRS) in patients with moderate to severe COVID-19. This approval marks Evergreen Therapeutics as the only innovative pharmaceutical company globally that currently possesses both oral and injectable therapies for COVID-19, signifying its comprehensive coverage of treatments for varying severities of CRS induced by the SARS-CoV-2 virus. On September 23, 2020, the Investigational New Drug (IND) application for EG-009, an oral capsule developed by Evergreen, was approved by the U.S. Food and Drug Administration (FDA). EG-009 is primarily indicated for the prevention and treatment of mild to moderate CRS caused by SARS-CoV-2. In contrast to EG-009, the newly approved injectable drug, EG-009A, is primarily indicated for the treatment of moderate to severe CRS caused by SARS-CoV-2. To address different stages of patient condition, Evergreen provides distinct routes of administration, striving to maximize bioavailability upon systemic entry while ensuring therapeutic efficacy.

According to epidemiologists, COVID-19 has become the most significant infectious disease threat to human life worldwide. By June 2021, the global number of COVID-19 infections is projected to reach 250 million, with 1.75 million deaths. Cytokine release syndrome (CRS) is one of the leading causes of mortality in COVID-19 patients; however, the various antiviral drugs currently under development do not simultaneously exhibit anti-CRS effects. CRS is a complex inflammatory response mechanism. During CRS, a massive production of multiple cytokines occurs in body fluids, leading to acute respiratory distress syndrome (ARDS) and multi-organ failure. Furthermore, some patients may experience a second cytokine storm after hospital discharge. EG-009 and EG-009A can inhibit the activity of multiple cytokines, thereby achieving therapeutic effects for moderate to severe COVID-19. Evergreen Therapeutics immediately initiated the research and development of its COVID-19 therapeutics following the outbreak. While preparing for clinical trials, the company also made substantial arrangements for basic research and patent applications related to its series of COVID-19 treatments. It is reported that the Phase I clinical trial of Evergreen’s oral formulation of EG-009 will be conducted in the United States in mid-November 2020 through a large international CRO. The Phase II clinical trial of Evergreen’s injectable formulation of EG-009A is also scheduled to commence shortly.

Dr. Xin Du, CEO of Evergreen Therapeutics, stated, “The approval of the Investigational New Drug (IND) application for EG009A marks a significant milestone in Evergreen’s development. Within a single month, Evergreen submitted three IND applications, all of which received early or on-schedule approval from the U.S. Food and Drug Administration (FDA). This serves as tremendous support and encouragement for a rapidly growing innovative pharmaceutical company, and reflects Evergreen’s accumulated strengths and well-strategized pipeline layout. Evergreen will continue to closely address urgent unmet clinical needs, further accelerate the advancement of various clinical trials, and optimize its other pipeline assets. Notably, while several anti-SARS-CoV-2 drugs are currently under development worldwide, Evergreen is the only innovative pharmaceutical company globally that simultaneously possesses both oral and injectable formulations for treating cytokine storm induced by SARS-CoV-2 infection. We express our gratitude to the FDA and our investors for their trust. We are racing against time to strive for the earliest possible availability of an effective therapeutic option for patients with COVID-19.”

About Evergreen Therapeutics

Shenzhen Evergreen Therapeutics Co., Ltd. (hereinafter referred to as “Evergreen”) is a rapidly growing, clinical-stage international biopharmaceutical company dedicated to the discovery and development of innovative drugs, as well as global clinical research and development and commercialization. The company’s mission is “Addressing Clinical Needs, Benefiting Patients Worldwide,” with a focus on the research and development of innovative therapies in the fields of autoimmunity, tumor immunology, and chronic diseases.

Evergreen Therapeutics adheres to a strategy of globalization and differentiation. While exploring new targets, the company actively pursues the development of new indications for existing drugs (Drug Repurposing). Drug Repurposing not only reduces research costs and accelerates R&D speed but also increases the probability of success and enhances drug value. In an era characterized by long development cycles and high costs for new drugs, Drug Repurposing is becoming a prevailing trend in pharmaceutical R&D. Evergreen’s corporate values of “closely monitoring clinical needs and accelerating innovative clinical development,” its development philosophy of “avoiding follower strategies in homogeneous hotspots and concentrating efforts on differentiated R&D,” and its development strategy of “maintaining a global perspective and focusing on drug value” will continue to lead future trends in the pharmaceutical industry.

Evergreen Therapeutics maintains an open mindset, vigorously advancing independent research and development while actively pursuing strategic collaborations. By seeking partnership opportunities worldwide to introduce high-quality products and first-class technologies, the company aims to promptly address patients’ urgent clinical needs and realize its corporate value.

For more information, please visit the official website of Evergreen Therapeutics: http://www.egpharm.com/