Swiss drugmaker Novartis is enlisting another drug from its portfolio in the fight against Covid-19 – this time a monoclonal antibody used to treat autoimmune diseases.
The Basel, Switzerland-based company said Tuesday that it was planning to start a Phase III clinical trial of Ilaris (canakinumab) to treat cytokine release syndrome in patients with Covid-19 pneumonia. The aim is to quickly enroll 450 patients in the U.S., U.K., France, Germany, Italy and Spain and then randomize them to receive Ilaris or placebo on top of standard-of-care treatment.
Ilaris targets interleukin-1 beta, also known as IL-1?, an inflammatory cytokine, which is a type of protein released by cells in the immune system. It has Food and Drug Administration approval for several rare autoimmune disorders. The launch of the study is based on lab tests of Covid-19 patients who showed elevated levels of cytokines like IL-1?.
Novartis is also part of a recently initiated Phase III clinical trial of Jakafi (ruxolitinib), a JAK inhibitor it markets with Incyte, with the latter company sponsoring the trial in the U.S. and Novartis sponsoring it in other countries. Novartis is also sponsoring a Phase III study of hydroxychloroquine, a malaria drug available as a generic, in hospitalized Covid-19 patients.
Cytokine release syndrome, or CRS, is a condition that results from large-scale release of cytokines into the blood stream due to an overreaction by the immune system and can occur in response to infections or treatments with therapies such as CAR-T cells for cancers, including Novartis’ own CAR-T product, Kymriah (tisagenlecleucel). Severe cases can potentially be fatal. Another drug being tested as a potential treatment to calm down the immune system in Covid-19 patients, Roche’s Actemra (tocilizumab), has FDA approval as a treatment for CRS related to use of Kymriah and other CAR-Ts.
Actemra works by targeting another inflammatory cytokine behind the hyperactive immune system reactions seen in Covid-19 patients, IL-16. An additional IL-16 inhibitor in development for Covid-19 is Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab). That drug, which is in a Phase II/III study, had somewhat of a setback this week as the Phase III portion of the trial was amended so that it only enrolls critically ill patients, following an analysis by the independent data monitoring community indicating that it was not effective in severely ill patients.