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Alexion will test rare disease drug Ultomiris in severe COVID-19

Phase 3 trial due to start in May

Alexion Pharma logo

Alexion Pharma has joined the ranks of drugmakers trying to repurpose established drugs to treat coronavirus patients, saying it will start a phase 3 trial of its Ultomiris product next month.

The study will enrol around 270 patients who have been hospitalised with severe COVID-19 symptoms, including pneumonia and acute respiratory distress syndrome (ARDS), across countries with a high number of coronavirus cases, says the company.

Complement C5 inhibitor Ultomiris (ravulizumab) is already approved to treat paroxysmal nocturnal haemoglobinuria (PNH) in Europe, the US and Japan, and in the US for atypical haemolytic uremic syndrome (aHUS), and has just been cleared by the FDA for testing in COVID-19.

The drug is a longer-acting follow-up to Alexion’s $4bn blockbuster C5 inhibitor Soliris (eculizumab), which has matched its parent drug for efficacy in trials – with a trend towards superiority – and offers improved dosing.

The rationale for trialling Ultomiris in COVID-19 comes from studies suggesting that inhibiting complement C5 can reduce cytokine and chemokine levels, which ramp up in some patients who contract SARS-CoV-2 causing inflammation and pneumonia in the lungs.

There’s also some data from some coronavirus patients who have gained access to Soliris via a compassionate-use programme in the US which suggests the drug can reduce lung injury caused by the virus. Alexion has now extended that programme to include France.

“We are aware of several ongoing or planned independent studies and anecdotal results from the use of our C5 inhibitors in patients with COVID-19,” says Alexion. Around 100 patients have received the drugs so far, and the company said the results “warrant conducting a controlled clinical programme”.

Ultomiris is a better option to test than Soliris because it has simpler weight-based dosing and requires fewer infusions, reducing the burden on healthcare systems. It can also be manufactured at higher capacity to meet global demand if it proves effective, says Alexion.

Interrupting the ‘cytokine storm’ that afflicts some patients with COVID-19 is the goal of a number of other drugs that have entered clinical testing, in the hope of rescuing the subset of patients who develop serious complications as a result of coronavirus infection.

Among these are Roche’s IL-6 inhibitor Actemra (tocilizumab), AstraZeneca’s BTK inhibitor Calquence (acalabrutinib), and two JAK inhibitors from Novartis/Incyte and Eli Lilly – respectively Jakafi/Jakavi (ruxolitinib) and Olumiant (baricitinib).

Alexion’s trial will test a preliminary loading dose of Ultomiris, followed by three more doses at days 5, 10 and 15, comparing the outcome to standard supportive care.

Article by
Phil Taylor

21st April 2020

From: Research



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