Novartis, already trialing hydroxychloroquine and Jakafi, plans COVID-19 testing for Ilaris

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Novartis plans to start a clinical trial of Ilaris in patients with COVID-19 pneumonia. (Novartis)

Another existing drug is being pitted against COVID-19. This time, it’s Novartis’ immunology med Illaris.

On Monday, Novartis said it planned to study Ilaris (canakinumab) in a phase 3 trial to see if the drug can reverse severe immune overreactions in patients with COVID-19.

The drug’s approved to treat several inflammatory diseases, including juvenile idiopathic arthritis. And it’s also under investigation in non-small cell lung cancer, with enrollment of newly diagnosed patients in a phase 3 clinical trial just completed in January.

A COVID-19 patient’s body might launch a potentially life-threatening immune response called cytokine release syndrome, or a cytokine storm, and cause serious organ damage as it fights the novel coronavirus. Early evidence from lab tests has shown COVID-19 patients experience elevated levels of IL-1beta—the target of Ilaris—among other cytokines, according to Novartis.

The trial aims to enroll 450 patients across France, Germany, Italy, Spain, the U.K. and the U.S. Patients will be split into two groups, receiving either Ilaris or placebo both on top of standard of care.

Investigators will primarily examine whether adding Ilaris can improve patient survival without the need for invasive ventilation. Top-line results are expected late summer.

RELATED: FDA warns hyped COVID-19 drug hydroxychloroquine is too risky outside the hospital

This marks the third COVID-19 clinical trial Novartis is sponsoring. Last week, the Swiss pharma won FDA clearance to test antimalarial drug hydroxychloroquine in a 440-patient study among hospitalized patients. The drug has won backing from President Donald Trump as a COVID-19 treatment, though it’s shown mixed results from multiple studies in different parts of the world. The FDA just warned that the chloroquine family of drugs may cause serious heart complications, emphasizing it only be used in emergency settings of hospitalized patients under close supervision.

Novartis, in collaboration with Incyte, is also rolling JAK inhibitor Jakafi—also known as Jakavi outside of the U.S.—into another phase 3 also for the management of cytokine storm.

As CEO Vas Narasimhan said during a Tuesday presentation, Novartis is also supporting 32 other investigator-initiated clinical trials testing its products—such as IL-17A inhibitor Cosentyx, leukemia drug Gleevec, old heart drug Diovan (valsartan) and asthma therapy Xolair—for their anti-viral or anti-inflammatory effects in COVID-19.

RELATED: After disappointing early numbers, Sanofi and Regeneron scale back Kevzara's COVID-19 test

Besides Novartis, several biopharma companies are working to repurpose their drugs against the new disease. For treating COVID-19-related cytokine storm alone, Roche is testing its arthritis drug Actemra after China reported clinical benefits from its use, and some early data just came out of France also suggesting it might work in severe and critically ill patients.

However, Sanofi and Regeneron just scaled back a study of rival IL-6 inhibitor Kevzara after the phase 2 lead-in portion of the clinical trial showed no notable benefit on clinical outcomes in severe patients despite its ability to lower C-reactive protein, a key marker of inflammation. Therefore, the pair has decided to only enroll only critical patients in the phase 3 part.

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