Eaglergen 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), Shenzhen Egret Medicine Co., Ltd. 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 submitted under the CTAP* program, which the FDA established specifically for COVID-19.The entire IND review took only 29 calendar days.

EG-009A is one of the top ten R&D pipelines at Aeglea Pharmaceuticals and will be primarily used to treat cytokine release syndrome (CRS) in patients with moderate to severe COVID-19.。This approval marks Aeglea Pharma as the only innovative pharmaceutical company globally to currently possess both oral and injectable therapies for COVID-19, signifying its comprehensive coverage of treatments for cytokine storms of varying severity induced by the SARS-CoV-2 virus. On September 23, 2020, the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for EG009, an oral capsule developed by Aeglea, primarily indicated for the prevention and treatment of mild to moderate cytokine storms caused by SARS-CoV-2. In contrast to EG009, the newly approved injectable drug, EG009A, is primarily indicated for the treatment of moderate to severe cytokine storms induced by SARS-CoV-2. By offering different routes of administration tailored to distinct stages of patient disease progression, Aeglea strives to maximize drug bioavailability while ensuring therapeutic efficacy.

According to epidemiologists, COVID-19 is currently the most significant infectious disease threatening 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 death among COVID-19 patients, while various antiviral drugs currently under development do not simultaneously exhibit anti-CRS effects. CRS is a complex inflammatory response characterized by the massive production of multiple cytokines in bodily fluids, leading to acute respiratory distress syndrome (ARDS) and multi-organ failure. Furthermore, some patients may experience a second cytokine storm after discharge from the hospital. EG-009 and EG-009A can inhibit the activity of multiple cytokines, thereby achieving therapeutic effects for moderate to severe COVID-19. Since the outbreak of COVID-19, Aigelin has immediately initiated the research and development of its COVID-19 therapeutics. While preparing for clinical trials, the company has also made substantial arrangements for basic research and patent applications related to its series of COVID-19 treatment drugs. It is reported that the Phase I clinical trial of Aigelin’s oral formulation of EG-009 will be conducted in the United States through a large international CRO in mid-November 2020. The Phase II clinical trial of Aigelin’s injectable formulation of EG-009A is also set to commence shortly.

Dr. Xin Du, CEO of Aeglea Pharma, stated, “The approval of the Investigational New Drug (IND) application for EG009A marks a significant milestone in Aeglea’s development. Within a single month, Aeglea submitted three IND applications, all of which received early or on-schedule approval and recognition from the FDA. This serves as tremendous support and encouragement for an innovative pharmaceutical company undergoing rapid growth, and reflects Aeglea’s accumulated strength and strategic pipeline portfolio. Aeglea will continue to closely monitor 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 globally, Aeglea is the only innovative pharmaceutical company worldwide that possesses both oral and injectable formulations designed to treat 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 to provide an effective therapeutic option for patients with COVID-19 as soon as possible.”

* Coronavirus Treatment Acceleration Program

Shenzhen Aigelin Pharmaceutical Co., Ltd. (hereinafter referred to as “Aigelin”) 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 to “address unmet clinical needs and benefit patients worldwide,” with a focus on the research and development of innovative therapies in the fields of autoimmunity, tumor immunology, and chronic diseases.

Eglin Pharmaceuticals adheres to a globalization and differentiation development strategy. 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 innovation. Eglin’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.

Eglin 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, Eglin aims to promptly address patients’ urgent clinical needs and realize corporate value.