Home Eglin Pharma’s EG-009 Receives FDA Approval for Phase I Clinical Trial in COVID-19 Treatment

Eglin Pharma’s EG-009 Receives FDA Approval for Phase I Clinical Trial in COVID-19 Treatment

Sep 24, 2020 10:42 CST Updated 10:42
Evergreen Therapeutics

Innovative Drug Developer

On September 23, 2020 (Eastern Time), Evergreen Therapeutics announced that the U.S. FDA had officially approved its Investigational New Drug (IND) application for Phase I clinical trials of EG-009, an oral capsule for the treatment of COVID-19. The IND application was reviewed under the Coronavirus Treatment Acceleration Program (CTAP*), a special pathway established by the FDA specifically for COVID-19 therapies. The entire IND review process took only 26 calendar days.

EG-009 is one of the nine R&D pipelines of Evergreen Therapeutics, designed to treat cytokine storms caused by COVID-19. Cytokine storm is one of the leading causes of death in patients with COVID-19. The oral formulation of EG-009 is primarily used for the prevention and treatment of cytokine release syndrome (CRS) induced by SARS-CoV-2 infection. Amid the ongoing global pandemic of COVID-19, the development of EG-009 offers new hope for reducing mortality rates among COVID-19 patients.

Evergreen Therapeutics immediately initiated the research and development of its COVID-19 therapeutic drugs following the outbreak of the pandemic. While preparing for clinical trials, the company also made substantial strategic arrangements for basic research and patent applications related to its series of COVID-19 treatments. Dr. Xin Du, CEO of Evergreen Therapeutics, stated, “Addressing clinical needs and focusing on drug value are the core principles we have always upheld. As a rapidly growing innovative pharmaceutical enterprise, the continuous adjustment and refinement of our R&D pipeline is a routine endeavor. Upon approval of the Investigational New Drug (IND) application for EG-009, Evergreen’s R&D team will immediately commence clinical trials for this project, striving to bring new therapeutic hope to patients with COVID-19 as soon as possible.”

About Evergreen Therapeutics

Evergreen Therapeutics (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 development and commercialization. The company’s mission is “Addressing Unmet Clinical Needs to Benefit 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 development strategy centered on 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 follow-on efforts in homogeneous hotspots and concentrating resources 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 cutting-edge technologies, the company aims to promptly address patients’ urgent clinical needs and realize its corporate value.