As of this morning – Tuesday April 14 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 88,621 with 11,329 deaths.
AstraZeneca has unveiled plans for a randomised, global clinical trial to test whether Calquence (acalabrutinib) could be used to treat the exaggerated immune response (cytokine storm) linked with COVID-19 infection in severely ill patients.
Calquence is a next-generation, highly selective BTK inhibitor currently used to treat certain types of blood cancers.
The CALAVI trial was designed on the back of “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.
The study is based on early clinical data with Calquence demonstrating that a decrease in inflammation caused by BTK inhibition appears to reduce the severity of COVID-19-induced respiratory distress, the firm said, adding that its goal is to evaluate whether adding the drug to best supportive care will reduce mortality and the need for assisted ventilation.
“Given the well documented role of the protein BTK in regulating inflammation, it is possible that inhibiting BTK with acalabrutinib could provide clinical benefit in patients with advanced COVID-19 lung disease,” said Louis Staudt, chief of the Lymphoid Malignancies Branch at the National Cancer Institute (NCI).
“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 large, multicentre, global, randomised trial uses a two-part patient-centric design “developed in record time” to accelerate data capture and analysis.
The first part will assess adding Calquence to BSC versus BSC alone in patients hospitalised with COVID-19 who are not in the intensive care unit (ICU). The second will evaluate the addition of Calquence to BSC in a cohort of patients in the ICU.
“With this trial we are responding to the novel insights of the scientific community and hope to demonstrate that adding Calquence 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,” commented José Baselga, executive VP, Oncology R&D, at the firm.
The CALAVI trial is expected to open for enrolment in the coming days in the US and several countries in Europe.
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