Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.
AstraZeneca has reported positive data from a case series involving its blood cancer drug Calquence (acalabrutinib) for the treatment of hospitalised patients with severe Covid-19.
Data showed that the drug reduced laboratory markers of inflammation and improved clinical outcomes in majority of 19 Covid-19 patients with severe hypoxia and/or inflammation.
The results from the case series have been published in Science Immunology journal.
AstraZeneca Oncology R&D executive vice-president José Baselga said: “The encouraging preliminary data in this case series has informed the initiation of global Phase II trials, notably the CALAVI programme.
“We look forward to completing recruitment and obtaining data in these trials as soon as possible to further our understanding of what this potential treatment could mean for patients.”
Calquence is a inhibitor of Bruton’s tyrosine kinase (BTK). In the US, the drug holds approval to treat some haematological malignancies.
The CALAVI programme involves two clinical trials to assess the safety and efficacy of Calquence given with best supportive care (BSC) versus BSC alone in hospitalised patients with respiratory complications of Covid-19.
These randomised, open-label, multi-centre, global trials will enrol patients who are hospitalised but not on assisted ventilation. One trial is being conducted in the US and the second study is in ex-US countries, including Europe, Japan and South America.
The primary efficacy endpoint is the number of patients alive and free of respiratory failure after treatment.
AstraZeneca announced plans in April this year to study Calquence to treat cytokine storm that manifests in severely ill Covid-19 patients.
CALAVI is based on scientific evidence that supports BTK pathway’s role in the generation of inflammatory cytokines and on the drug’s favourable early clinical data.
The company is conducting the clinical programme in partnership with investigators across the US, including those at the National Cancer Institute of the National Institutes of Health.