Russian pharmaceutical company R-Pharm is working to retool rheumatoid arthritis drug, olokizumab, to treat COVID-19 patients with moderate to severe infections, its Chief Medical Officer Mikhail Samsonov told Reuters in an interview.
Final results of a 372-person placebo-controlled, randomized clinical trial, are due to be published in late October or early November, Samsonov said, but the drug has been included in national guidelines for treating patients with moderate COVID-19 infections and early signs are encouraging.
Other drugmakers' attempts to re-purpose rheumatoid arthritis drugs for COVID-19 have had mixed results. Sanofi’s Kevzara has failed in a trial while Roche’s Actemra was shown to reduce the need for ventilation in patients.
Belgium's UCB, the initial developer of olokizumab, sold a development and marketing license for the drug to R-Pharm in 2013.
R-Pharm's move is another sign Russia is pushing hard to take a global lead in the race to fight the COVID-19 pandemic that has claimed more than a million lives.
It is already exporting its COVID-19 tests and has clinched several international deals for supplies of its Sputnik-V vaccine.
Last month, Russia approved R-Pharm's Coronavair drug to treat mild and moderate COVID-19 cases. The approval of the prescription drug followed the green light for another Russian COVID-19 drug, Avifavir, in May.
'CYTOKINE STORM'
R-Pharm started work on retooling olokizumab in February, when reports of growing cases and deaths worldwide began to appear, and completed recruitment for the trial in June, Samsonov said.
Olokizumab belongs to a class of drugs called interleukin-6 inhibitors that are being tried to help regulate a dangerous over-reacting to the virus by the body's immune system called "cytokine storm."
"What we saw in the clinical trial and in clinical practice is that when we inject the monoclonal antibody, olokizumab, within a few hours the temperature is going down, oxygenation is growing," Samsonov said.
The benefit of R-Pharm's drug is that a single 64mg dose, administered by injection, binds directly to circulating cytokines and helps to suppress hyperinflammation and prevent the development of serious lung damage, he added.
The speed of Russia's vaccine rollout, which the Russian government approved for use before completing large-scale human trials, has elicited concern from scientists about its safety and efficacy.
Samsonov said that although olokizumab is being used in some clinics across Russia already, it was still far from widespread use and that safety was a primary concern.
"COVID is not universal, patients react differently. For some patients certain combinations work and are more effective and safe, for others it may be different," he said.