Coronavirus: the response to the crisis by Pharmacology

(To Maria Grazia Labellarte)
19/03/20

The new virus - SARS-CoV-2 - is arousing great concern in almost all the world health systems and in particular, at this moment, in that of our country as it is absolutely new and against which there are no approved treatments or vaccines to combat it. the diffusion.

In recent weeks, public organizations and biotechnology companies across Europe have stepped up their efforts to tackle what we might call "the Great Crisis".

We proceed with an excursus of interventions that at least will help us understand the "response to the crisis by Pharmacology".

Let's start by recalling that the European Commission has funded projects for the development of vaccines, treatments and diagnostics through certain grants from the "Horizon 2020" project and the Joint Technology Initiative on Innovative Medicines (IMI), a public-private partnership between the European Commission and the pharmaceutical industry by announcing up to € 45 million in public grants to fund studies. IMI expects pharmaceutical companies to co-invest for a total amount of 90 million euros. IMI's response to this Covid-19 outbreak has been honed by lessons learned from previous outbreaks, most notably Ebola viral disease.

Then there are the British charity The Wellcome Trust, the Bill and Melinda Gates Foundation and Mastercard, which have launched an initiative of 110 million euros (125 million dollars) to promote public-private collaboration and accelerate the arrival of Covid-19 treatments on the market.

In terms of vaccine development, therapeutic drugs, diagnostics and research, the biotechnology industry in Europe is becoming a key part of this struggle. Apparently Sanofi and Janssen are both collaborating with the US Biomedical Advanced Research and Development Authority (BARDA) to develop preclinical vaccines. An advanced program is a collaboration between the Oslo-based public-private funder Coalition for Epidemic Preparedness Innovations (CEPI) and the German biotech CureVac to develop a vaccine against Covid-19 mRNA.

A few days ago, an investment of around 3 million euros in Horizon 2020 funding went to a Danish public-private partnership for the development of a vaccine for Covid-19, including the biotechnology companies ExpreS2ion Biotechnologies and AdaptVac. The consortium intends to start a phase I / IIa clinical trial for a vaccine within 12 months. Israel's Vaxil Bio also reported "proteins" that could act as a vaccine for Covid-19. The Italians are also active, including Takis Biotech in collaboration with the American manufacturer Applied DNA Sciences and the scientists of the University of Oxford in collaboration with the Italian biotechnology Advent. A research team at Imperial College London aims to launch clinical trials in early summer if they receive funding. 

We recall the collaboration between the Danish university and Immunitrack, with the latter having published a report on some of the most promising viral structures of the coronavirus strain at the beginning of March. The British Native Antigen Company has also introduced the field of vaccines by launching coronavirus antigens for research purposes, which could accelerate efforts to develop vaccines and diagnostic tests.

Roquette of Switzerland is aiming for a more indirect approach, with the development of molecules called cyclodextrins that could make vaccines more stable and easier to manufacture antiviral drugs.

If the first vaccines could reach their most advanced stage by the summer, according to the Labiotech source, "regulatory bodies will likely require one to two years of human testing to ensure the vaccine is safe and effective." Once approval is obtained, companies must begin commercial-scale production and distribution of the vaccine, which takes time, so the world could see an approved Covid-19 vaccine available by mid-2021.

Antiviral drugs, old and new are in sight… Numerous companies plan to develop new antiviral drugs or to adapt existing experimental drugs to fight the new virus. But antiviral drugs are difficult to develop because, unlike bacteria, viruses hide in our own cells. This means that drugs to stop viruses are more likely to affect our cells and cause serious side effects.

Austrian biotechnology Apeiron launched a Phase II pilot clinical trial in late February for a "candidate" drug for the treatment of Covid-19. The protein drug has already completed Phase I and II studies for the treatment of acute lung injury and is designed to work by mimicking a protein that coronavirus attaches to when it invades lung tissue.

Scientists from the laboratories in Göttingen and Berlin, Germany, are currently investigating the potential of a drug approved in Japan for the treatment of inflammation of the pancreas and for protecting against coronavirus by blocking a protein vital for the function of the virus. Another effort to reuse antiviral drugs took place at the Norwegian University of Science and Technology. The authors of a study published in the International Journal of Infectious Diseases have identified 31 approved antiviral drugs that have the potential to treat or prevent Covid-19, such as lopinavir and ritonavir.

In addition, with regard to Italy, we cite the latest news reported by Repubblica which tells us that "over the weekend four other patients admitted to the Cotugno hospital in Naples were treated with Tocilizumab, the anti-arthritis drug with which they are treating some patients who tested positive for coronavirus. In total there are therefore 11 patients treated in Naples with the off-label drug following an experiment born from the collaboration between the director of the Uoc of oncology of the Colli hospital, Vincenzo Montesarchio, and the director of the unit of melanoma oncology, oncological immunotherapy and innovative therapies of the Pascale institute in Naples, Paolo Ascierto.

While, therefore, much attention is paid to vaccines and drugs, diagnostics for Covid-19 cannot be overlooked either.

In the United States, official tests for the disease were found to contain faulty reagents, casting doubt on the accuracy of the disease case figures in the United States. "The priority is to be able to stratify patients for clinical trials of new or repurposed drugs and to be able to quickly identify people with the virus, ideally through a diagnostic test, so that e.g. doctors could able to diagnose people on the spot "(Source Labiotech). In this way, people who have the virus can be isolated and treated immediately, but people who don't have it can continue with their daily lives.

A few weeks ago, British biotechnology Mologic received a 1,1 million euro grant from the British government and The Wellcome Trust to fund the development of a portable diagnostic device that detects Covid-19 in 10 minutes without the need for a laboratory or electricity. The company is also working to manufacture the device in Africa to manage potential outbreaks on that continent.

The German company Genekam also launched one of the first tests for the coronavirus behind Covid-19 in early February, which was for research purposes only. Even with the most accurate and fastest diagnostic tests, containment measures are also important.

However, as China's quarantine and social distancing policies and ours these days have shown, these are a valuable potential to contain the epidemic. The Chinese quarantine has been very pressing and rigorous and in my opinion this should not be the time to ask "democratic dilemmas" that limit freedom of movement, especially the protection of the national health system, grappling the coming weeks with the Southern dilemma , where tens of thousands of people residing in the Red Zones have decided to return to their homeland, the unknown of the data from South Korea remains (always if true) where it is assumed, even on a voluntary basis, that the most high number of swabs, also performed on the asymptomatic, strangely attributable to a large number of young people between 20 and 30 years, and then isolated. Could this be a valid logistic solution?