AstraZeneca (AZN - Free Report) will initiate a global clinical study — CALAVI — to assess the potential of its BTK inhibitor drug, Calquence (acalabrutinib) for treating exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients.
Please note that Calquence is approved to treat previously treated mantle cell lymphoma and chronic lymphocytic leukemia indication (in frontline as well as relapsed/recurrent disease setting).
The two-part CALAVI study is designed based on strong scientific evidence supporting that BTK pathway has a role in the production of inflammatory cytokines (signaling proteins). Inhibition of BTK pathway with Calquence could provide clinical benefit in patients with advanced COVID-19 lung disease. Early clinical data demonstrated that Calquence’s highly selective BTK inhibition leads to decrease in inflammation which appears to reduce the severity of COVID-19-induced respiratory distress.
One part of the CALAVI study will evaluate the efficacy and safety of adding Calquence to best supportive care (“BSC”) in patients hospitalized with COVID-19 who are not on assisted ventilation and not admitted in the intensive care unit (“ICU”) compared to BSC alone. Another part of the study will evaluate the same regimen in patients who are admitted in the ICU with more severe respiratory complications.
The company hopes that adding Calquence to BSC may reduce the need to place patients on ventilators and also improve their chances of survival. It plans to start enrollment in the CALAVI study soon in the United States as well as several European countries.
AstraZeneca’s shares have declined 2.4% so far this year compared with the industry’s decrease of 7.1%.
The company joins the rank with other large pharma companies who are evaluating their marketed drugs’ role in possible inhibition of immune response, which can lead to potential benefits in COVID-19 patients.
Earlier this week, Lilly (LLY - Free Report) signed an agreement with the National Institute of Allergy and Infectious Diseases to evaluate its JAK inhibitor, Olumiant, as a potential treatment for hospitalized patients diagnosed with COVID-19. Roche (RHHBY - Free Report) and Regeneron (REGN - Free Report) /Sanofi have already initiated clinical studies to evaluate their IL-6 receptor antagonists, Actemra and Kevzara, respectively, in severe COVID-19 patients.
Please note that Olumiant, Actemra and Kevzara are approved for rheumatoid arthritis, an autoimmune disorder. These drugs are also being predicted to reduce overactive inflammatory response in the lungs leading to improvement in coronavirus-infected patients.
Several other large and small pharma/biotech companies are developing treatments or vaccines to fight the pandemic, which infected nearly 2 million people worldwide.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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