Novartis has plans to conduct a Phase III clinical trial to assess canakinumab (Ilaris) for the treatment of patients suffering from Covid-19 pneumonia.
Canakinumab is an interleukin (IL)-1β blocker indicated to treat certain periodic fever syndromes, such as cryopyrin-associated periodic syndromes and systemic juvenile idiopathic arthritis.
The new Phase III trial, called CAN-COVID, will evaluate the drug’s efficacy in treating a type of severe immune overreaction called cytokine release syndrome (CRS) related to Covid-19 pneumonia.
CRS is known to cause life-threatening complications in these patients.
The study is said to be based on early findings from lab tests of Covid-19 patients who had elevated IL-1β levels, among other cytokines.
Novartis intends to recruit 450 participants at various medical centres in France, Germany, Italy, Spain, the UK and the US.
Participants will be given canakinumab or placebo along with standard of care (SoC).
The primary objective of the trial is the benefit of canakinumab plus SoC in improving the chance of survival without requiring invasive mechanical ventilation in patients with Covid-19 pneumonia.
Top-line data from CAN-COVID are expected to be available later this year.
Novartis said in a statement: “This trial initiation is part of the overall Novartis approach to applying our best science to tackling the issues related to Covid-19 and further underscores Novartis commitment to quickly deploy R&D resources, medicines, clinical expertise and philanthropic aid to combat Covid-19.”
Canakinumab is the third drug candidate to be studied by the company for Covid-19 treatment.
Novartis, in alliance with Incyte, is assessing Jakavi (ruxolitinib) in a Phase III trial to treat cytokine storm in patients with severe Covid-19 pneumonia.
In addition, Novartis entered an agreement with the US Food and Drug Administration (FDA) to conduct a Phase III trial of hydroxychloroquine to treat hospitalised Covid-19 patients.