Firms may find it ‘difficult’ to co-market combined Covid-19 drugs, says analyst

Jamie Bell 19th May 2020 (Last Updated May 19th, 2020 08:19)

Currently, one of the most prominent Covid-19 treatments being trialled is a combined approach involving remdesivir and baricitinib

Firms may find it ‘difficult’ to co-market combined Covid-19 drugs, says analyst
Remdesivir is marketed by US pharma firm Gilead Sciences, while baricitinib is sold by Eli Lilly

Companies such as Gilead Sciences and Eli Lilly working together to develop combined Covid-19 treatments will find it “difficult” to co-market drugs, says an analyst.

The two firms, which are investigating a combination of remdesivir and baricitinib (Olumiant) to treat severely ill coronavirus patients, may face challenges further down the line — especially because these medicines cannot be integrated into a single regimen.

Michael Breen, infectious diseases expert at analytics company GlobalData, said: “It may be the case that each developer would supply their products to governments and allow them to determine distribution of the drugs — as Gilead is doing now with remdesivir.

“They could both benefit financially, however, significant profits may be unlikely as any efforts to set high prices for a drug in times of crisis could carry significant negative consequences, particularly in terms of perception.”

 

Latest on remdesivir-baricitinib trials

Gilead announced on 29 April that its own SIMPLE study had demonstrated positive results, and raised no serious safety concerns, regarding the use of remdesivir to treat Covid-19 patients.

Further promising preliminary data was then produced in the ACTT study, which was run by American research centre NIAID (National Institute of Allergy and Infectious Diseases), and saw a 31% increase in recovery time for coronavirus patients compared to those administered with a placebo.

There was also an 8% mortality rate for those treated with remdesivir, compared to 11.6% for those given a placebo.

The next stage of the ACTT study was announced by NIAID on 8 May, with more than 1,000 participants across the US being enrolled in a clinical trial to test a combination of remdesivir and baricitinib — a rheumatoid arthritis (RA) treatment marketed by Eli Lilly under the name Olumiant.

In these randomised controlled trials, some patients are being treated with remdesivir combined with baricitinib, while the rest are given remdesivir alongside a placebo. This will assess whether recovery times are shorter when remdesivir is used in combination with baricitinib, compared to when it is used on its own.

It’s thought that baricitinib may be effective in inhibiting viral infections, and reducing the damage done to the lungs during a “cytokine storm” — a negative immune response triggered by respiratory diseases like Covid-19.

 

Combined Covid-19 treatments

Expectations over how soon a combination of remdesivir and baricitinib may be available should be tempered, according to Breen, because the second phase of the ACTT study has only just begun.

“We must factor in how long it will take to design the study, enrol patients, and execute the study,” he added.

“The length of time for each patient to be treated could be as little as two weeks, and, if the trial was rapidly initiated, data could be available by summer.

“However, we have to also factor in that there may not be enough of each drug, particularly remdesivir, to support a rapid, large-scale roll-out.”

While remdesivir is now being considered the “standard of care” in severely ill Covid-19 patients, Breen believes the precise use of baricitinib at present is “unclear” because there is no evidence of its efficacy in treating the disease.

Baricitinib’s relevance in treating Covid-19 arose from using BenevolentAI to identify intracellular targets which might be involved in virus uptake and thus it potentially could be used in conjunction with remdesivir to drive a synergistic response against the virus,” he added.

“At the moment, it’s very difficult to say which combination could be the most successful because — aside from remdesivir — very few monotherapies have demonstrated efficacy, and the few that have shown positive data have come from small, sometimes uncontrolled studies.

“Right now, it’s anyone’s game. IL-6 inhibitors stand out because IL-6 has been implicated in the disease progression of Covid-19.”

On 16 March, French pharma firm Sanofi and US biotech company Regeneron announced trialling of the IL-6 (Interleukin-6) inhibitor sarilumab — another rheumatoid arthritis drug known commercially as Kevzara — had begun.

Reports by GlobalData suggest that, similarly to JAK1/JAK2 inhibitors like baricitinib, IL-6 inhibitors may be effective as an anti-inflammatory to reduce the damage done by a cytokine storm.