Il-yang Pharmaceutical said it has obtained Russian approval to evaluate its leukemia drug Supect in a phase-3 trial to treat the new coronavirus. Supect is Korea’s 18th novel drug.
Alpharm, a Russian drug company, will lead the phase-3 study on Supect.
Earlier, Il-yang and Alpharm submitted an investigational new drug application to the Russian authorities and received the green light to go ahead with the trial on Wednesday.
“Supect is the first among Korean Covid-19 treatment candidates to win an overseas regulator’s nod for a clinical trial,” Il-yang Pharmaceutical said in a press release.
As the drug is an authorized medicine that has already proved safety, it could be commercialized faster than other candidates for Covid-19, the company added.
Il-yang hoped that Supect would be the first case of drug repurposing outside the country among Korean-made original drugs.
On April 21, Il-yang agreed that Alpham would pay all the expenses for a Covid-19 treatment trial and Il-yang would provide Supect for testing. Il-yang has completed manufacturing samples of Supect for the trial in Russia and plans to send them to Alpharm in early June, the company said.
Supect will be tested in 145 patients with mild and severe Covid-19 at 11 medical institutions in Russia and neighboring country Belarus. After two weeks of drug administration, researchers will evaluate its therapeutic effect.
Il-yang will allow Alpharm to own the exclusive right to use the result of the study and the sales rights of Supect in Russia and Belarus only. Il-yang will have the right to use the study result in other countries.
Russia is witnessing a rapid rise of Covid-19 confirmed cases, with new daily cases hovering at around 8,000 to 10,000. Russia’s number of Covid-19 patients is the world's third-largest after the U.S. and Brazil. Infections were initially concentrated in Moscow but are now spreading towards the outskirts of the capital city.
According to Il-yang, Supect reduced the Covid-19 virus by 70 percent in an in vitro lab test at Korea University College of Medicine’s Bio Safety Level 3 (BSL-3) facility, compared to the placebo group, within 48 hours.
<© Korea Biomedical Review, All rights reserved.>