AstraZeneca reported that the CALAVI Phase II trials of Calquence (acalabrutinib) in hospitalized patients with respiratory symptoms of COVID-19 failed to meet the trials’ primary efficacy endpoint.
Bruton’s tyrosine kinase (BTK) inhibitors are used to suppress autoimmune diseases. In COVID-19 patients with severe symptoms that include pneumonia, their symptoms are believed to be an immune system reaction, such as the cytokine storm. The goal was to test if Calquence, which suppresses some of the immune system, can be effective in controlling that aspect of COVID-19.
The CALAVI Phase II program is made up of two trials of Calquence with best supportive care (BSC) compared to BSC alone in patients hospitalized with respiratory complications of COVID-19. Patients were randomized 1:1. The patients were hospitalized, but not on mechanical ventilation and were not in the intensive care unit. The primary endpoint measured
respiratory failure or death. The trial was run in the U.S. (CALAVI US) and in several other countries (CALAVI). The AstraZeneca-University of Oxford COVID-19 vaccine program is running about third in U.S. and European development programs, behind the Pfizer-BioNTech group and Moderna.
In mid-October, AstraZeneca inked a $486 million deal with the U.S. government to fund two Phase III trials of its anti-SARS-CoV-2 antibody cocktail, AZD7442. AstraZeneca’s approach uses half-life extending technologies, and the company believes it could prevent infection against the virus for up to 12 months. The deal secured up to 100,000 doses for the U.S. supply by the end of the year, with an option to buy up to 1 million doses in 2021.