AstraZeneca initiates a new clinical trial, following the science and working with the medical community to address the urgent need of patients
We are starting a new clinical trial evaluating how one of our existing medicines might help alleviate the exaggerated immune response that can result in pneumonia, respiratory failure and death of patients hospitalised with COVID-19 infections. The trial design is based upon strong scientific evidence supporting the role of the Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory cytokines, and on encouraging early clinical data.
This trial will assess how one of our existing medicines might help alleviate the “cytokine storm” associated with the disease – when the immune system can overreact and attack vital organs like the lungs and the liver.
This large, multicentre, global, randomised trial uses a two-part patient-centric design developed in record time to accelerate data capture and analysis. José Baselga, Executive Vice President, Oncology R&D, said: “With this trial we are responding to the novel insights of the scientific community and hope to demonstrate that adding our medicine to best supportive care reduces the need to place patients on ventilators and improves their chances of survival. This is the fastest launch of any clinical trial in the history of AstraZeneca.”
Louis M. Staudt, M.D., Ph.D., Chief of the Lymphoid Malignancies Branch at the National Cancer Institute (NCI), said: “As with all new treatments, it will be necessary to gather data from clinical trials in order to understand the best and safest treatment options for patients.”
The trial is expected to open for enrolment in the coming days in the US and several countries in Europe. Wyndham H. Wilson, MD, PhD, of NCI in the US, will serve as the principal investigator of the trial. Louis M. Staudt, MD, PhD will serve as senior investigator.
With the COVID-19 pandemic claiming thousands of lives daily, AstraZeneca is putting patients first by prioritising response to this pandemic, consistent with company values to follow the science, put patients first and do the right thing. AstraZeneca priorities are to ensure the continued supply of our medicines to patients, and to safeguard the health and wellbeing of all our employees and communities.