Keeping tabs on Covid-19: Results announced from WHO solidarity trial and BD bring immune assessment solution to Europe

Solidarity trial produces conclusive evidence of the effectiveness of subcutaneous treatment in patients hospitalized with coronavirus

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A solidarity clinical trial “is one of the largest international randomized trials for Covid-19 treatments, enrolling almost 12,000 patients in 500 hospital sites in over 30 countries”, according to the World Health Organization (WHO), which launched the trail with a number of partners. As WHO releases results on the effectiveness of repurposed drugs for the treatment of Covid-19, it has come to light that subcutaneous interferon (IFN) beta-1a was found to be ineffective, but that the intravenous formulation of Traumakine could have positive results.

In this week’s update, Pharma IQ share updates from WHO’s solidarity clinical trial and a new treatment option in Europe to help clinicians receive a better understand the Covid-19 patient immune response.

WHO concludes subcutaneous treatment is ineffective in hospitalized Covid-19 patients

Results from the WHO's solidarity trial showed that subcutaneous IFN beta-1a was found to be safe, but ineffective in reducing overall mortality in hospitalized patients with Covid-19.

The WHO’s intent-to-treat analysis compared 1,412 patients who received IFN beta-1a with 2,050 control subjects not receiving IFN beta-1a. Overall, in-hospital mortality was 12.9 per cent in the IFN beta-1a group and 11 per cent in the control group.

At the time this data was gathered, WHO introduced Faron Pharmaceuticals’ intravenous formulation of IFN beta-1a, Traumakine, into the trial’s observation period. The WHO has not been able to verify how many patients received Traumakine at the time of this analysis but confirmed approximately half of patients receiving IFN beta-1a also received concomitant corticosteroids.

Dr. Markku Jalkanen, CEO of Faron Pharmaceuticals, said: “These first results from the solidarity trial are disappointing, given the need for new therapeutics to support the global response to Covid-19. They do support our long-held view that IFN beta-1a is likely to be ineffective when given subcutaneously.

“The science behind Traumakine and its potential to prevent multi-organ failure, through the upregulation of the key endothelial enzyme CD73, is compelling and we continue to believe that an intravenous formulation of IFN beta-1a is what patients need, to strengthen the body’s own IFN beta signaling – the first line of defense against viral infection – and provide optimal exposure to the lung vasculature.

“Compared to subcutaneous IFN beta-1a, the same amount of intravenous IFN beta-1a achieves over 150 times higher peak concentration in the lung vasculature without higher systemic exposure, which we believe makes this method of administration highly effective and safe. We will continue to pursue the science behind this,” Dr. Jalkanen added.

BD announces test for immune assessment of Covid-19 patients now available in Europe

Becton, Dickinson and Company (BD), a medical technology company, has brought a time-tested immune assessment solution to European clinicians treating Covid-19 patients.

BD’s multi-test tubes have been CE-approved for trading in the European Economic Area, with expanded clinical application for the identification and enumeration of T-cell subtypes in Covid-19 patients. The testing techniques have been used previously to assess immune function in HIV patients and may now help clinicians to better understand the Covid-19 patient immune response, and when used in conjunction with clinical findings and laboratory testing, inform patient treatment plans and prioritize precious resources.

According to BD scientist’s, data from the first global wave of Covid-19 shows that patients typically exhibiting a decrease of CD4 and/or CD8 lymphocyte counts with increasing disease severity.

Puneet Sarin, worldwide president, biosciences at BD, said: “The availability of this product with the expanded clinical application in Covid-19 patients is an important step in helping clinicians better understand how patient immune systems are responding to Covid-19 infection.

“Bringing [BD’s] expertise to clinicians treating Covid-19 patients presents a great opportunity to enable deeper immune assessment of patients, which could lead to improved uses of precious resources within a hospital while helping get patients on the right clinical path,” he added.

In an effort to encourage innovation and get new products out to market faster in response to the Covid-19 pandemic, regulatory design is adapting to become more proactive, dynamic and responsive to innovation and digital transformation. Discover how regulation in biotech can be both a barrier and a solution for innovating the drug discovery process as the pharma industry shifts from blockbuster products toward new individualized forms of medicine in Pharma IQ’s report.