Californian company – a front-runner in race to find anti-viral drug – awaits results from Wuhan trial

As  the global   Covid-19  toll  mounts,  with  6494 deaths so  far,   how close  are  new  drugs   to  treat   the disease?

Point of  Order  has been searching  international media for news of   the   work  of    much-criticised  Big  Pharma  and found  at   least  11  companies engaged in  developing  anti-viral drugs  to be used in treatment  against the  disease.

The  most advanced of   these  appears  to be  California-based Gilead Sciences, which for the past few years  has been developing Remdesivir, an anti-viral with promising results in lab and animal studies against SARS, MERS, Ebola and other infectious diseases, including Covid-19.

Remdesivir is already  being tested in Wuhan, the centre of the epidemic, and the US National Institute of Health  has indicated the drug would also be studied in some of the patients who contracted the illness overseas and are now being treated in  the US.

In its   latest report Gilead said  it  is expanding its clinical trials of Remdesivir as a possible coronavirus treatment into several countries outside China. These trials will  involve

“ … approximately 1,000 patients at medical centres primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases,”

Results from the trials in Wuhan are expected in April, the company said.

The drug is still experimental, not yet approved to treat any disease. Studies of infected mice and monkeys have suggested that Remdesivir can fight coronaviruses, and it appeared to cause few side effects when it was tested in patients with Ebola, although it did not work well against that virus.

The experimental drug also stirred interest after doctors administered it to the first coronavirus patient in the US. The man was hospitalised in Washington State and his symptoms seemed to improve. But the experience of one patient cannot be used to determine whether any drug works.

If  the  Phase 3 clinical trials  are successful, the big  question  is  how  quickly will  the  US  Food and Drug Agency   move  to give  the drug  its approval  for public  use.

Researchers are trying to determine which patients Remdesivir might help most, by giving the drug to people who are severely ill and also some who are not as sick. They also hope to find out how long a course of treatment is needed.

Because it’s an outbreak and we try to target people who stand to have a clear benefit, first we target people who are symptomatic, so they are hospitalised,” Dr. Diana Brainard, Gilead’s senior vice president for H.I.V. and emerging viruses, said.

There is a precedent in respiratory viral infections, that the earlier you treat, the better, and there may be a threshold beyond which it doesn’t make sense to treat.

On the other hand, she said, if the drug does help severely ill patients, that could be its greatest impact.

Another goal of the new trial is to find out if a shorter course of treatment will work.  If a shorter duration does work, she said, “that automatically doubles the drug supply.”

Faster treatment would also get patients out of the hospital faster, lessen their exposure to hospital-based infections and make room for more patients, she added.

One of the new trials will include 400 severely ill patients, who will be picked at random to receive either five days or 10 days of treatment with the drug, which must be given intravenously.

The other trial will involve 600 moderately ill patients. Along with standard care — oxygen if needed, fluids, medicines for pain and fever — a third will receive the drug for five days, and a third for 10 days. The last third will receive standard care alone.

A World Health Organisation assessment from February described Remdesivir as the “most promising candidate” against COVID-19.

A  survey  of other  firms  involved  in  seeking  Covid-19 treatments included  the  following:

 AbbVie

AbbVie manufactures the co-formulation lopinavir/ritonavir, which is used to treat HIV. It  is collaborating  with  health authorities  to see if it can be used as a treatment against Covid-19, based on unconfirmed reports in China that its use was helpful in combating it. It has provided the drug to several countries, including China, as an experimental option.

Moderna

Cambridge, MA-based biotech startup Moderna has developed  a  potential  mRNA vaccine against Covid-19. The vaccine was developed in collaboration with scientists at the National Institute of Allergy and Infectious Diseases. The vaccine works by getting the immune system to develop antibodies against a   “spike  protein” found on the virus. A batch of the vaccine has been manufactured and delivered for a first round of testing. The vaccine was developed, manufactured and sent out for testing just 42 days after the coronavirus DNA sequence was first published.

Johnson & Johnson

Pharmaceutical giant Johnson & Johnson has partnered with the Biomedical Advanced Research and Development Authority, a federal agency that helps develop countermeasures to biological threats, to develop potential vaccines and treatments for Covid-19. The company is working to identify molecules in its libraries that might be effective against the disease. It’s also leveraging technologies that were used to successfully develop an ebola vaccine towards finding promising vaccine candidates.

In addition to looking at new therapies, Johnson & Johnson has sent batches of its HIV drug darunavir/cobicistat to China to test its efficacy against Covid19.

Eli Lilly

Indiana-based pharmaceutical company Eli Lilly is partnering with Vancouver-based biotech firm AbCellera to co-develop antibody-based treatments against Covid-19. The firms have already discovered “hundreds” of antibodies that might be effective against the disease, with the next step being to screen those for the most effective treatment candidate.

In 11 days, we’ve discovered hundreds of antibodies against the SARS-CoV-2 virus responsible for the current outbreak,” AbCellera CEO Carl Hansen said in a statement.

Pfizer

Pfizer  has  reported  it has discovered several promising anti-viral molecules that stop the SARS-CoV-2 virus from reproducing in cells in the lab. The candidates are currently being screened to identify the best candidates to move into the development pipeline. The company’s Chief Science Officer, Mikael Dolsten, says  the company might also consider exploring the combination of these molecules with anti-viral treatments developed by other firms.

GlaxoSmithKline

GSK has previously developed a pandemic vaccine adjuvant platform, a system that helps to improve vaccines by strengthening the immune response in patients who receive it.  The company is partnering with the Coalition for Epidemic Preparedness Innovations to use that platform to improve potential vaccines to the new coronavirus. As part of that collaboration, it signed an agreement with the University of Queensland, Australia, which is developing a potential vaccine.  GSK has also partnered with Chinese pharmaceutical company Clover to use its adjuvant platform with that company’s COVID-19 vaccine candidate.

Regeneron Pharmaceuticals

The New York-based biotechnology company is expanding its collaboration with the Department of Health and Human Services, which has already resulted in a potential ebola treatment. In that collaboration, the company is looking to identify potential antibody therapies that could be useful against Covid-19.

Sarilumab, a rheumatoid arthritis treatment Regeneron developed with Sanofi, is to be tested as a potential Covid-19 treatment.

Inovio Pharmaceuticals

Pennsylvania-based pharmaceutical company Inovio Pharmaceuticals has announced it has  accelerated  the timeline  for its vaccine candidate INO-4800. The company has previously developed a vaccine for MERS that’s in the testing phase. According to a statement, the company’s CEO has said it could begin human testing of the vaccine in April.

Vir Biotechnology

San Francisco-based Vir Biotechnology announced March 12 that it’s going to be collaborating with BioGen to manufacture antibodies that may have potential to treat Covid-19. The company has identified antibodies from people who recovered from SARS, and is studying to see if they might be active against the new coronavirus, as the two are very similar. Vir is also working with federal agencies to advance its research against other coronaviruses.

In February, Vir announced it’s working with Chinese pharmaceutical firm WuXi Biologics on this research as well.

Sanofi 

French pharmaceutical company Sanofi  is collaborating with BARDA to expedite a Covid-19 vaccine, leveraging technology already in use in development of a SARS vaccine. The company says that it will use its recombinant DNA tech with an aim of finding an exact genetic match to the surface proteins of the virus.

The vaccine is in development. Sarilumab, a rheumatoid arthritis treatment Sanofi developed with Regeneron, is to be tested as a potential Covid-19 treatment.

NZ  might  not  be in the front of the  queue  if and when   any of these  anti-viral  drugs make  it to  market—but  at  least  it  would be benefit  from  the signal the  march of the disease  is being halted and, as a  consequence, the global economy would be  returning to something like the normality of the pre-pandemic  era.

 

 

 

 

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