Bayer’s Canadian subsidiary is partnering with the country’s Population Health Research Institute (PHRI) on a major clinical research program aimed at identifying potential treatments for COVID-19.

 Two studies are planned, both aimed at evaluating the safety and efficacy of different combination therapies including the Bayer products chloroquine and interferon beta-1b in combating the virus.

The German group will make a financial commitment of C$1.5 million ($1.1 million) toward the studies and will supply study drugs to support the research. This adds to the C$0.5 million committed by the PHRI earlier this month, which enabled the development of the research program.

The Canadian authority plans to enroll 6,000 patients in the two studies from more than 60 contributing research sites across the province of Ontario and beyond.

Specifically, said Salim Yusuf, PHRI’s executive director, an outpatient study will evaluate the combination of chloroquine with azithromycin (the combination touted by US president Donald Trump, and already used in some small-scale trials), to see if this treatment can prevent deterioration leading to hospital admission.

A second study will evaluate the combination of chloroquine with azithromycin as well as interferon beta-1b to prevent admission to intensive care, mechanical ventilation and/or death to combat COVID-19.  “Our goal,” Yusuf, said, “is to assess the value of these and other therapies rapidly so that the results can inform practice as soon as possible.”

“Treatments against COVID-19 are urgently needed as no validated options are currently available,” Mike Devoy, a member of the executive committee of Bayer’s pharmaceuticals division and chief medical officer, stressed. “We want to contribute to the global fight against the coronavirus through our products and expertise and look forward to partnering with the PHRI.”

Chloroquine was developed by Bayer in the 1930s and has been employed as a malaria drug for decades as well in disease management for lupus and rheumatoid arthritis.

In March, Bayer donated 3 million doses of Resochin to the US government to use in trials as a potential treatment for the novel coronavirus. Soon afterward, the US Food and Drug Administration (FDA) at the president’s urging authorized it as an experimental treatment outside of the established indications.

The German pharmaceutical and agrochemicals group’s donation subsequently came under scrutiny following a Reuters report that suggested that facilities manufacturing the drug in India and Pakistan did not meet FDA quality requirements.

Interferon beta-1b in a recombinant formulation (brand name Betaseron/Betaferon) was picked up by Bayer in the takeover of former German drugmaker Schering in 2006. It was the first drug to show a decrease in relapse rate in multiple sclerosis (MS) and to reduce MS disease activity as measured by MRI in clinical studies.

Drugmakers and health authorities worldwide are exploring a plethora of drugs and drug combinations in the fight against COVID-19, in the hope that some of them will help patients.

Outside the US and France, health authorities have remained skeptical of the prospects for chloroquine and hydroxychloroquine as a COVID treatment, and in the UK it has been banned in this application except in clinical trials. 

No trials with interferon beta-1b have been reported as yet.