The late-stage trial will evaluate the use of Jakavi for the treatment of cytokine storm associated with the novel coronavirus infection
Jakavi to be investigated as a potential treatment of cytokine storm associated with COVID-19. (Credit: Thor Deichmann from Pixabay)
Novartis said that it will initiate a phase 3 trial in collaboration with Incyte to assess the use of the cancer drug Jakavi (ruxolitinib) in severe COVID-19 patients.
The late-stage trial will evaluate the drug’s use for the treatment of cytokine storm associated with the novel coronavirus infection. Cytokine storm is a type of severe immune overreaction that can result in life-threatening respiratory complications.
According to Novartis, the decision to move ahead with the clinical trial has been driven by pre-clinical evidence and preliminary reports from independent studies. Furthermore, the decision is backed by the data on the safety and efficacy of Jakavi in conditions such as acute graft versus host disease and myeloproliferative neoplasms, said the Swiss pharma company.
The phase 3 trial will evaluate the drug in combination with standard of care (SoC) therapy, in comparison to SoC therapy alone, in patients having severe COVID-19 pneumonia arising from SARS-CoV-2 infection.
Novartis chief medical officer and drug development global head John Tsai said: “Novartis is taking a number of steps to address the urgent needs arising from the COVID-19 pandemic, including the evaluation of our existing therapies to assess if any can be utilized beyond their approved indications.
“The potential that Jakavi could lead to faster recovery times for COVID-19 patients with fewer requiring intensive care and mechanical ventilation is encouraging and absolutely merits further investigation.
“We now are moving rapidly to finalize the study plan and then to enroll eligible patients, as well as put in place a process to provide access for patients unable to participate in the trial.”
Jakavi is an approved blood cancer drug in the European Union
Jakavi, which is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, has approval in the European Union for the treatment of polycythemia vera (PV) in adults who are resistant to or intolerant of hydroxyurea. The drug is also approved in the region for the treatment of disease-related splenomegaly or symptoms in adults having primary myelofibrosis (MF), post-polycythemia vera MF or post-essential thrombocythemia MF.
Novartis had licensed Jakavi from Incyte for the development and commercialisation in certain indications outside the US.