Novartis/Incyte draw blank with Jakafi in COVID-19

Novartis/Incyte’s Jakafi (ruxolitinib) looks unlikely to be added to the list of therapies that can be used against COVID-19, after it failed to cut complications or death in a phase 3 trial.

Data from the phase 3 RUXCOVID study showed that there was no significant reduction in the proportion of COVID-19 patients on ruxolitinib plus standard therapy experiencing severe complications, compared to standard care alone.

Severe complications included death, respiratory failure requiring mechanical ventilation or admission to intensive care.

RUXCOVID is a 29-day placebo-controlled trial testing ruxolitinib in 432 patients aged 12 years or over in patients hospitalised for COVID-19 and not intubated or receiving intensive care before randomisation.

Results were measured against a composite primary endpoint of patients who died, developed respiratory failure requiring mechanical ventilation, or required admission to ICU by day 29.

But the proportion of people meeting this endpoint was almost identical in the two groups – 12% for those treated with ruxolitinib and 11.8% for those treated with placebo plus standard care.

Patients were randomised 2:1 to receive ruxolitinib twice daily or oral-matching placebo for 14 days, with standard therapy decided according to the investigator’s clinical judgement.

Ruxolitinib is already FDA approved under the brand name Jakafi to treat the bone marrow diseases myelofibrosis, polycythemia vera and graft-versus-host disease.

Trials of the drug in other indications are not affected by the outcome, Novartis said.

The drug is an oral inhibitor of JAK 1 and JAK 2 tyrosine kinases and the rationale behind the trial was to investigate whether the down regulation of the immune system conferred by the medicine would reduce the inflammation caused by COVID-19.

Originally developed by Incyte, Novartis licensed in the drug for development and marketing outside the US.

The RUXCOVID trial is sponsored by Novartis outside of the US and by Incyte inside the US.

Many drugs are being trialled against COVID-19, with the cheap steroid dexamethasone producing some of the most promising trial results.

Although Gilead’s Veklury (remdesivir), an antiviral originally intended to treat Ebola, is approved in the US to treat COVID-19 the World Health Organization has recommended against using it because of differing interpretations of trial results.