BeiGene, a global biotechnology company, announced that the phase 2 trial evaluating Brukinsa (zanubrutinib) in patients hospitalized with respiratory symptoms of Covid-19, requiring supplemental oxygen without mechanical ventilation, did not meet the co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen as compared to placebo. There were no new or additional safety signals for zanubrutinib identified in the trial.
“I am proud of the work by our teams at BeiGene and our research partners to further the understanding of the potential for BTK-inhibition against Covid-19-related respiratory distress. While the outcome of this phase 2 trial is disappointing, I am heartened by the speed at which we mobilized to launch a clinical trial to explore if zanubrutinib might be able to help in the global fight against Covid-19,” said Jane Huang, M.D., chief medical officer, Hematology, at BeiGene. “Our mission has been to explore ways we can help patients around the world, supported by scientific rigor and well-designed and executed trials like this.”
BeiGene initiated patient enrollment in a phase 2 trial in the US evaluating zanubrutinib for the treatment of patients with Covid-19-related pulmonary distress in May 2020.
Brukinsa (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists. It is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
