The race to develop Covid-19 drugs and vaccines is on — here’s what’s happening in the UK
Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.
On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.
Interferons, a family of naturally occurring proteins secreted by the immune system, typically boost the body’s immune response to uninvited guests such as viruses, bacteria and cancer.
“When we’ve collected cells from patients with COPD and asthma and older people…we find that their lung cells don’t respond very well to viruses,” CEO Richard Marsden said in an interview. “We have also along the way always recognized that with an emerging virus, the drug could be used.”
As Covid-19 started to gather steam in China, Synairgen tried to get things started, but to no avail. Italy was the next plan. “We had some really good interaction there,” said Marsden. “But they went from, you know, just busy to very busy to extremely busy to unable-to-communicate busy.”
Eventually, they decided their home ground — the UK, where they have an ongoing COPD trial — would be the best place to kick off a Covid-19 study. Initially, the pilot phase of the trial will have 100 patients (50 will get a placebo, and 50 will get SNG001). If all goes well, a pivotal study will be conducted.
This approach is one of many, as companies race to design and develop diagnostics, drugs and vaccines to stem the tide of the pandemic. “(W)e need high quality clinical research to work out what is working, what isn’t working; we believe placebo-controlled trials are the way to do that,” Marsden said.
Last week, the UK government issued a statement confirming that the two decades-old malaria drugs: chloroquine and hydroxychloroquine, which have been touted as potential treatments for patients infected with the coronavirus, have not been sanctioned for use against the virus in the UK.
Although clinical trials are ongoing, no conclusions have been reached on the safety and effectiveness of these medicines, noted the Medicines and Healthcare products Regulatory Agency. In stark contrast, in the United States, the FDA on Sunday issued emergency authorization for the pair of drugs that President Donald Trump has repeatedly backed, on the basis of anecdotal reports.
In the UK, scientists at Oxford University are also looking at repurposing other drugs for use against Covid-19. Last week, researchers announced they would be testing lopinavir-ritonavir, approved used to treat HIV, and the steroid dexamethasone, in consenting adults that have tested positive for Covid-19 in NHS hospitals. The project, in which patients will either get one of the two drugs, or placebo in addition to standard-of-care treatment, has won £10.5 million in government funding.
“The streamlined design of this clinical trial allows consenting patients to be enrolled in large numbers easily and without compromising patient safety or adding significantly to the workload of busy hospitals and their staff,” said the trial’s deputy chief investigator Martin Landray, who also serves as a professor of medicine and epidemiology University of Oxford, in a statement.
Vaccines in the works
Oxford researchers also have a vaccine candidate in place.
On January 10 — long before the coronavirus infection was named Covid-19 or assumed pandemic proportions — a team of Oxford researchers led by Professors Sarah Gilbert, Andrew Pollard, Adrian Hill and Dr. Sandy Douglas had begun their search for a vaccine. On March 18, they honed in on a candidate: a chimpanzee adenovirus vaccine vector (ChAdOx1).
Chimpanzee adenoviral vectors are well studied, having been used in vaccines targeting over 10 different diseases. The Oxford vaccine contains the genetic sequence of the surface spike protein found on SARS-CoV-2 — the virus behind Covid-19 — inside the ChAdOx1 construct. If the project is successful, vaccination with this product will produce the surface spike protein of the coronavirus, priming the immune system to attack the coronavirus if it later infects the body.
The researchers — who have previously developed a vaccine for MERS that showed promise in early clinical trial — said last week they would start screening people for a clinical trial, although the vaccine is still weeks away from being ready for human testing. The enrollment goal is to hit 510 volunteers, and work is being done to scale up manufacturing in haste.
About a two-hour drive away, researchers at the University of Cambridge also have a Covid-19 vaccine in the works.
Professor Jonathan Heeney, head of the laboratory of viral zoonotics and chief of spinoff company DIOSynVax, has spearheaded research, aided by computer modeling of the virus’ structure.
By putting the genetics of the virus under a microscope, the company has identified a key part of the genetic code that the virus uses to produce the essential part of its coat: the spikes, which is what the vaccine is engineered to target.
“A vaccine strategy needs to be laser specific, targeting those domains of the virus’ structure that are absolutely critical for docking with a cell, while avoiding the parts that could make things worse,” he said in a statement. “Our technology does just that.”
Preclinical trials are yet to be conducted, but he expects the vaccine candidate could be ready for human trials by June. Funding, however, is required.
“We need a ‘Big Pharma’ partner to help us scale up our activities,” he said.
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