Italians promise breakthrough: short-cure antibodies will drain Europe’s hospitals

These are the same drugs that effectively cured former US President Donald Trump, infected with the virus, in just a few days in the fall. True, virologists soon quenched global enthusiasm for the effects of miracle therapy: yes, monoclonal antibodies block the penetration of the virus into the human body, but this treatment is only available to those who can spend a million dollars. The debate over the miracle cure for COVID-19 ended there: what is possible for Trump is impossible for the average American or European.

And here is the unexpected message: “The Italian government has reserved a special fund for the production of monoclonal antibodies, we already have access to tens of thousands of patients,” said Nicola Magrini, director general of the Italian Medicines Agency. It turned out that the short antibody cocktail was made by the American company Bsp Pharmaceuticals in Latina, Italy, near Rome. The difficult-to-pronounce drug, bamlanivimab, is already being mass-produced at 100,000 doses per month, with 2 million ampoules planned by 2021.

Is a feeling? There will be a scandal! It turned out that in October last year, the Americans proposed to the Italian government to start clinical trials, but the country’s pharmaceutical agency, AIFA, allegedly rejected this option. According to the Rome daily Il Fatto Quotidiano, the main reason for this refusal was that neither the US FDA nor the European EMA had approved the mass production of monoclonal antibodies. The US FDA has allowed the use of antiviral drugs only in rare cases and during investigations.

The great interest and debate on the use of monoclonal antibodies in the treatment of cystic patients is due to the fundamental impact of this therapy in the development of the pandemic: the possibility of emptying overcrowded hospitals. Studies from the University of Alabama show that of the 550 patients who received the antibody cocktail, only 15 continued treatment in hospital. Everyone else recovered at home. Several predictions of the effect of antibody therapy on patient hospitalization are presented, but they are all quite optimistic: 70 to 90 percent. fewer hospitalized for COVID-19.

The relatively high cost of a single injection of monoclonal antibodies remains a major problem for this treatment: it is no longer a million, but only 1.5-2 thousand euros. Italian pharmaceutical analysts are confident that the cost of antibody therapy will drop significantly in the near future. However, given that a day a patient spends on a COVID-19 specialized resuscitation in Italy costs at least € 3,000, even the current cost of antiviral drugs would represent significant savings.

The Italians promise a breakthrough for Europe: a much cheaper topical monoclonal antibody preparation has already been developed and launched here.

Interest in it has increased further thanks to pharmacists’ knowledge of the equally potent effects of antibodies on all currently known COVID-19 mutations.

In the Tuscany region, Mad Lab di Toscana Life Sciences’ pharmaceutical production line is supported by one of the most powerful retail chains in Italy, Coop, and the country’s Ministry of Economy has invested 15 million euros. In early summer, Italy plans to market 200,000 doses of antibodies at market prices.

Antibodies? This is not a vaccine, but a medicine!

A journalist from Delfi spoke about monoclonal antibody therapy with Professor Giuseppe Remuzzi, one of the most famous Italian pharmaceutical specialists, director of the Mario Negri Pharmacological Research Institute in Milan.

– Teacher, explain how monoclonal antibody therapy works in treating infected COVID-19.

– When an infection enters our body, the body begins to produce antibodies that attack the uninvited host and try to eliminate it. In COVID-19 infection, our antibodies attack a specific element of the virus: the ‘spike’ protein, called the ‘spike protein’. These spikes emerge from the SARS-Cov-2 virus capsule and adhere to the cell’s ACE2 receptor, penetrating our body, which in turn begins to produce antibodies that block the spike protein.

Researchers select from humans exactly the specific antibodies needed to fight the virus, copy them, and reproduce them in the laboratory. Antibodies processed into a drug preparation are injected intravenously into the patient through a drip.

– From which human organ are monoclonal antibodies isolated?

– From human blood plasma. In Singapore, for example, a person has been identified with extremely potent antibodies that are very effective against spike-like proteins.

– Is this a reliable enough way to fight a rogue virus?

– Yes, I think it is one of the most effective weapons to prevent the virus in our body. If we could vaccinate and immunize all healthy people and treat those affected with monoclonal antibodies, it would mean a final victory over COVID-19, just as it did in the fight against Ebola or the smallpox virus.

– Has Italy already started monoclonal antibody therapy? How much does a dose of therapy currently cost?

– Yes, in Rome, in Milan, we already started using this treatment after our drug agency AIFA authorized the use of antibody therapy a few days ago. Currently, a dose costs about 2,000 euros. Please note that this method of treatment is not available in the hospital and is not suitable for those patients who require pulmonary ventilation or oxygen.

– So, in which cases is antibody therapy more effective?

– It is more effective if treatment is started within the first ten days after infection or from the first symptoms of the disease. Theoretically, this should be a home therapy, but under medical supervision. In a word, some organizing effort would be needed here, for example, if the ambulance teams (the doctor, the nurses) could go home and connect a drip with an antibody preparation, monitor the patient’s condition.

As I said, the most important thing is not to be late, to reach that stage of aggression on the fifth or sixth day after infection, which is crucial.

– Perhaps monoclonal antibody therapy could replace vaccination?

– Vaccination is intended for healthy people to prevent infection. Antibodies must be administered to already infected people to avoid further disease progression and hospital burdens. However, these pandemic methods do not replace each other. Also, keep in mind that we now know that in the later stages of the disease, when respiratory failure occurs, antibody therapy will not be effective.

– Did Italy do the right thing without waiting for the EMA’s verdict on antibody therapy?

– I think our AIFA did the right thing. There is an inconclusive but sufficiently motivated clarity on the facts that monoclonal antibodies block the virus. If a few weeks ago we talked about this treatment not being effective it is only because we have been experimenting with random patients and at the wrong time.