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Can IL-6 Drugs Cut Coronavirus Death Rate? Sanofi and Regeneron Take Trial To Worst Hit Countries

The shocking death toll from COVID-19 continues to mount daily around the world, with nearly 38,000 lives taken by the virus so far, with Italy and Spain now bearing the greatest losses.

IL-6 drugs have been among the drugs used in the emergency setting in critically ill patients, and their use could help cut deaths, but no robust trials have yet read out to demonstrate their true impact. Now Sanofi and Regeneron Pharmaceuticals Inc. are acting swiftly in starting an international trial of their IL-6 drug Kevzara (sarilumab), including in countries worst hit by the pandemic.

Hope that the drugs could work is based on a single arm trial in China of Roche's IL-6 drug Actemra (tocilizumab), conducted at the height of the country's outbreak. This saw a group of 21 patients experience rapidly reduced fevers, and 75% of patients (15 out of 20) reduced their need for supplemental oxygen within days of receiving the drug. 

Based on these results, China updated its COVID-19 treatment guidelines and approved the use of Actemra to treat patients with severe or critical disease - and Roche will shortly begin its own Phase III trial to collect more robust data.

The biggest causes of deaths from COVID-19 include pneumonia and acute respiratory distress syndrome (ARDS) in patients critically ill from COVID-19, and it is thought the drugs targeting the IL-6 pathway can address this life-threatening inflammation seen in these patients.

Earlier this month Sanofi and Regeneron kicked off a US-based Phase II/III trial of Kevzara in the US, but have now extended it to several more countries, including those most badly affected by COVID-19 mortalities.

The global clinical program has now begun in Italy, Spain and France - all severely hit by deaths. Italy has by far the biggest death toll, which rose to 10,781 on 30 March, while Spain has now overtaken China with 6,528 deaths. Also included in the trial is Germany (which has a very low COVID-19 mortality rate) and Canada, Russia and the United States. These countries have so far escaped the worst of the disease, but the US in particular is expected to see its total number of cases and deaths leap upwards in the coming days and weeks.

The companies say they are working with health authorities around the world to secure initiation at additional sites. 

"Data from a single-arm study in China suggest that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19,"  said George Yancopoulos, co-founder, president and chief scientific officer of Regeneron.

"Despite this encouraging finding, it's imperative to conduct a properly designed, randomized trial to understand the true impact of Kevzara, which we are now doing through this global clinical trial program,"In addition to the Kevzara program, Regeneron continues to rapidly advance a novel antibody cocktail for the prevention and treatment of COVID-19."

Yancopoulos said earlier this month that data from these trials could be available in just weeks or months.

However mortality will not be an endpoint in this new Phase II/III trial. Rather, it will use adaptive trial design to determine the best way to move into Phase III, and select endpoints, patient numbers and doses, but nevertheless, it is hoped Kevzara's use could help save lives.

Roche is ready to begin its Phase III trial of Actemra/RoActemra (tocilizumab), meanwhile, which will include mortality as an endpoint, and hopes to initiate the trial in early April.

J&J/BARDA Alliance Hopes To Yield COVID-19 Vaccine By Early 2021

Johnson & Johnson and the US Biomedical Advanced Research and Development Authority (BARDA) announced a $1bn effort for novel coronavirus vaccine research on 30 March, with the pharma also noting it has selected a lead vaccine candidate and two backups that it hopes to bring into clinical testing by September.

Begun in January, J&J’s COVID-19 vaccine research based on genetic sequencing of the virus produced multiple constructs using the AdVac technology platform, which generated the lead candidate now moving into manufacturing first steps. J&J hopes to begin a Phase I study in September and produce clinical safety and efficacy data before the end of 2020. If successful, this could result in a vaccine available for emergency use in early 2021, the company said.

The pharma also said it has committed scaling up its manufacturing capacity so that it eventually could produce one billion doses of a vaccine. (Also see "J&J Ramps Up Manufacturing Capacity To Produce 1 Billion Doses Of Candidate COVID-19 Vaccine" - Pink Sheet, 30 Mar, 2020.) The $1bn collaboration with BARDA will fund research, development and clinical testing, including money to expand J&J’s ongoing work to identify novel antiviral treatments against the novel coronavirus. The pharma also is allocating personnel and infrastructure to the effort on a global basis.

J&J said it will begin its vaccine production work on an at-risk basis and is committed to bring an affordable vaccine for emergency pandemic use to the public on a not-for-profit basis.

Astellas Modifies Trial Activity Based On Local Situation

Astellas Pharma Inc. is introducing changes to clinical trial operations in countries with rapid growth of new COVID-19 cases.

The Japanese firm is suspending start-up activities involving study sites for new interventional clinical studies in these countries, and is also suspending enrollment of new patients in ongoing studies. In countries no longer experiencing rapid COVID-19 case growth, study activities are being continued or resumed. 

In line with guidance from US and EU regulators, Astellas said it is assessing protocols and implementing measures to reduce the burden on healthcare systems while ensuring patient safety. “We will frequently reassess this approach, which applies to all interventional clinical trials led by Astellas and its subsidiaries and affiliates,” the company said.

Korea's GeneOne Selected As Vaccine Bidder

GeneOne Life Science Inc. of South Korea has been selected as the preferred bidder in the Korea Centers for Disease Control & Prevention’s project to develop a COVID-19 vaccine candidate using a RNA vaccine platform.

GeneOne Life aims to proceed rapidly with development based on its global clinical trial experience of with  MERS and Zika virus vaccines. Its DNA and mRNA platforms are geared up to develop vaccines for new infectious diseases.

The company said it will cooperate with research institutes and university research teams both at home and abroad to evaluate the new vaccine’s ability to prevent new coronavirus infections. Earlier this month, GeneOne Life said it is developing an RNA vaccine against COVID-19 in a cooperation with the Houston Methodist Hospital in the US.


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