Benzinga | Jun 18, 2021 10:47AM EDT

Evergreen Therapeutics Announces Agreement With ICON Plc To Conduct Phase II Clinical Trial For COVID-19 Drug Candidate

Evergreen Therapeutics, Inc. ("Evergreen," or the "Company"), a fast-growing clinical stage company focused on the development of new drugs for unmet medical needs, today announced a clinical service agreement with ICON plc ("ICON") to conduct a global, multi-center Phase II clinical trial for Evergreen's COVID-19 drug therapy candidate EG-009A.

ICON plc has been hired as Evergreen's Clinical Research Organization ("CRO"), to take the lead role in managing the company's Phase II clinical trial and overseeing the study's medical testing responsibilities. The first patients with COVID-19 are expected to be enrolled in early August 2021, and the Phase II clinical trial is expected to be completed by the middle of 2022.

This clinical trial will be conducted in the United States, Brazil, and Argentina, and will be a randomized, double-blinded, and controlled study. The purpose of the study is to evaluate the efficacy of Evergreen's EG-009A drug candidate for the treatment of moderate to severe COVID-19 cases. According to the requirements and recommendations of the FDA, the phase II clinical trial should be designed to show evidence of clinical significance in reducing pulmonary failure and improving the survival rate of hospitalized COVID-19 patients.

Dr. David Du, CEO of Evergreen Therapeutics, commented, "Evergreen Therapeutics is pleased to partner with ICON plc, the world's second largest clinical trial service organization, to serve as our CRO and arrange the Company's Phase II clinical study for our COVID-19 injection drug candidate EG-009A. ICON was the clear partner of choice for Evergreen, given their extensive experience in the research and development of new drugs for the prevention and treatment of COVID-19."

Dr. Du further commented, "We are excited that our pipeline EG-009A has achieved a clinical breakthrough while the COVID-19 pandemic is raging around the world. EG-009A is an innovative drug candidate to treat moderate to severe coronavirus caused pneumonia, and to inhibit the cytokine release syndrome (CRS). CRS is a critical and primary cause of death in a variety of viral infectious diseases, such as Ebola, SARS, viral influenza and other conditions. Since the beginning of 2020, we have conducted significant fundamental research and secured patent protection for the clinical development of EG-009A, and we are now entering the clinical stage for this drug candidate. We are very grateful for the guidance of the FDA, the partnership with ICON, and the strong support of investors. In March of 2021, we completed a $15 million USD equivalent Series A financing with several institutional investors. The proceeds from this offering will allow Evergreen to fund this Phase II clinical study."