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COVID-19 Roche starts clinical trial as UK cases continue to rise. As of this morning – Thursday 19th March – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 2,626, with 104 deaths and 65 recoveries.
As defense secretary Ben Wallace has announced a new military force ready to support public services as required during the crisis, pharma companies are continuing to pitch in with help where they can.
Roche has now announced the initiation of a Phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalized patients with severe COVID-19 pneumonia.
The pharma giant says that it is working with the Food & Drug Administration (FDA) to initiate the randomized, double-blind, placebo-controlled study, to evaluate the safety and efficacy of the drug in combo with the standard of care.
This is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US.
Roche has confirmed that primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
The trial is in order to “better establish the potential role for Actemra/RoActemra in fighting this disease,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development. “In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”
The news comes as a survey has revealed that 51% of millennials think fewer than half (40% or less) of the UK population will become infected, despite Government warnings this figure could rise to as much as 80%.
The findings, published by OVID Health and Deltapoll, focuses on how different generations are responding to the outbreak of COVID-19 and reveals that many millennials are not heeding official Government advice to wash their hands more regularly to slow the spread of the virus.
Further to the findings, the companies claim that one in five (21%) of 18-24-year olds have stockpiled food or other items; compared to only 11% of those aged 65+.
The World Health Organisation (WHO) urges the public to stay aware of the latest information on the COVID-19 outbreak, with information available through your national and local public health authority.
Wash your hands frequently
Regularly and thoroughly clean your hands with an alcohol-based hand rub or wash them with soap and water.
Maintain social distancing
Maintain at least one meter (three feet) distance between yourself and anyone who is coughing or sneezing.
If you have fever, cough and difficulty breathing, seek medical care early
Stay home if you feel unwell. If you have a fever, cough and difficulty breathing, seek medical attention and call in advance. Follow the directions of your local health authority.
COVID-19: Sanofi, Moderna, BioNTech give updates
Following government issued advice to avoid all non-essential travel and contact in the UK, various pharmaceutical companies are stepping up to offer vaccine candidates, funding and more.
The announcements come as Boris Johnson has made it explicitly clear that anyone who can be working from home, and up to 1.5 million people with the “most serious health conditions” must avoid almost all social contact for 12 weeks, from this weekend.
He also urged against gathering in places such as pubs and bars, leaving the hospitality sector at large to ponder over its future and ability to survive in the unprecedented circumstances.
In response to the growing outbreak, now officially classified a pandemic by the World Health Organisation (WHO), Sanofi and Regeneron Pharmaceuticals have announced that they have initiated a clinical program evaluating whether IL-6 inhibition with Kevzara (sarilumab) is better than current supportive care alone for patients hospitalized with severe COVID-19.
Regeneron says it is set to begin enrolling patients in Phase II/III study, while Sanofi’s global R&D chief John Reed said: “we expect to rapidly initiate trials outside the US in the coming weeks, including areas most affected by the pandemic, such as Italy.”
The companies detailed that in the Phase II part of the study, participants will be randomized to receive a low or high dose of Kevzara or placebo, with he primary endpoint being the reduction of fever, while the secondary goal is decreased need for supplemental oxygen.
Kevzara, which is approved to treat patients with moderately to severely active rheumatoid arthritis, was jointly developed by Sanofi and Regeneron under a global collaboration agreement signed in 2007.
BioNTech and Fosun Pharmaceutical have also detailed plans to advance BioNTech’s mRNA vaccine candidate BNT162 in China for the prevention of infections.
Fosun Pharma says that it will pay BioNTech up to $135 million in upfront and potential future investment and milestone payments, with the companies sharing any eventual profits from the sale of the vaccine in China.
The companies say the collaboration as an “important step in our global effort to expedite the development of our mRNA vaccine to prevent COVID-19 infection,” commented BioNTech chief executive officer Ugur Sahin, noting that Fosun Pharma “brings deep development experience and an extensive network in the pharmaceutical market in China.”
The two businesses will work jointly on the development of BNT162 in China, leveraging Fosun Pharma’s clinical development, regulatory and commercial capabilities in the country.
Another company pitching in is Moderna, who announced the dosing of a first subject in its Phase I study of experimental mRNA vaccine mRNA-1273 against SARS-CoV-2.
The American company says that the study aims to recruit a total of 45 healthy adults, ages 18 to 55 years, over a period of approximately six weeks, evaluating three dose levels of mRNA-1273.
“This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2,” remarked Moderna’s chief medical officer Tal Zaks, adding “we are actively preparing for a potential Phase II study.” The company noted that manufacturing is currently underway for mRNA-1273 material that would be used in a potential mid-stage trial, which could begin “in a few months.”
The Coalition for Epidemic Preparedness Innovations (CEPI) also recently warned that a funding gap of about $2 billion could potentially hamper the development of a vaccine against COVID-19.v