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Novartis to test canakinumab for COVID-19, as IL-6 trial disappoints

The drug could treat the rise in cytokine levels which causes inflammation and pneumonia


Novartis has said it will start a large-scale trial of its interleukin-1β inhibitor canakinumab as a treatment for the immune complications that afflict some people with COVID-19.

Canakinumab is already marketed as Ilaris as a once-monthly injection for systemic juvenile idiopathic arthritis (SJIA) and periodic fever syndromes (PFS), and Novartis has now joined the ranks of companies vying to develop the first therapy that could help aid COVID-19 patients’ recovery.

The CAN-COVID trial builds on preliminary evidence from laboratory tests of COVID-19 patients who showed elevated IL-1β levels, among other cytokines, says Novartis.

The hope is that the drug will treat the rise in cytokine levels – known as a cytokine storm – which causes inflammation and pneumonia in the lungs of some people infected with the coronavirus.

Novartis intends to recruit around 450 patients into the study at sites in France, Germany, Italy, Spain, UK and the US, who will be treated with either canakinumab or placebo on top of standard care for COVID-19.

The primary objective of the study is to demonstrate the benefit of canakinumab in increasing the chance of survival without the need for invasive mechanical ventilation, says Novartis, which thinks it could have results available in the late summer.

Other antibody drugs being tested for their potential to interrupt the cytokine storm in COVID-19 include Alexion’s complement C5 inhibitor Ultomiris (ravulizumab) and two IL-6 inhibitors – Roche’s Actemra/RoActemra (tocilizumab) and Sanofi/Regeneron’s Kevzara (sarilumab).

Small-molecule drugs are also being tested in this setting, including AstraZeneca’s BTK inhibitor Calquence (acalabrutinib), and two JAK inhibitors from Novartis/Incyte and Eli Lilly – respectively Jakafi/Jakavi (ruxolitinib) and Olumiant (baricitinib).

On Monday, Regeneron said preliminary results from a phase 2 trial of Kevzara had yielded mixed results, with little benefit outside a group of critically-ill patients that suggest IL-6 inhibitors could be only marginal players in COVID-19.

A day later, however, and independent researchers in France have reported that Actemra hit the mark in a controlled trial in 124 moderate to severe COVID-19 patients, with a lower death and ventilation rate among patients on Roche’s drug, although for now there isn’t any hard data to support the claim.

Roche has its own phase 3 trial ongoing – called COVACTA – that should provide evidence for the role of Actemra in coronavirus infections when it reads out later this year.

Novartis has previously tried to get approval for canakinumab as a treatment to prevent stroke and myocardial infarction (MI) or death in patients who have already suffered a heart attack, but withdrew marketing applications in the US and Europe amid resistance from regulators.

The drug is, however, still in trials as a treatment for non-small cell lung cancer (NSCLC) which Novartis has suggested could elevate the drug into blockbuster territory. It made $671m last year from its use in SJIA and PFS, and Novartis has just reported a 41% rise in first-quarter sales to $213m.

The company is running trials in both the first- and second-line settings in NSCLC, and has previously said it plans regulatory filings for this use in 2021.

Article by
Phil Taylor

29th April 2020

From: Research



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