Evergreen Therapeutics Covid-19 drug candidate, EG-009A, will be trialled in a Phase II study after the company partnered with ICON on a clinical service agreement.
EG-009A is designed to treat moderate to severe Covid-19 pneumonia and hinder cytokine release syndrome (CRS), the company noted.
CRS is a key cause of death in various viral diseases, including influenza and SARS infections.
The multi-centre, randomised, double-blinded and controlled Phase II clinical trial will assess the efficacy of EG-009A in treating Covid-19.
To be carried out in the US, Brazil and Argentina, the first subjects are anticipated to be enrolled in August this year. Evergreen plans to conclude the trial by mid-next year.
As per the US Food and Drug Administration (FDA) guidance, the Phase II trial design should focus on demonstrating clinically significance in lowering pulmonary failure and enhancing the survival rate in hospitalised Covid-19 patients.
As per the agreement, ICON will act as Evergreen’s clinical research organisation (CRO) to aid in managing the trial. ICON will be responsible for the trial’s medical testing activities.
Evergreen Therapeutics CEO Dr David Du said: “Evergreen Therapeutics is pleased to partner with ICON, the world’s second-largest clinical trial service organisation, 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.”
Over last year, Evergreen carried out research and obtained a patent to clinically develop EG-009A.
Furthermore, the company raised $15m in a Series A funding round in March this year. Evergreen will use the proceeds to finance the Phase II trial of EG-009A.
Evergreen has more than ten drug candidates in development and has a management team with research and development expertise.