In recent days, requests have increased for Regeneron’s experimental coronavirus drug that US President Donald Trump has called “a blessing from God” after receiving it to treat her COVID-19 case. However, the drug is not yet available on the market and is in the initial stages of its experimentation. Furthermore, despite the enthusiastic statements, there is currently no evidence to support for certain that it was that specific drug that reduced Trump’s symptoms, given that the doctors had made him take several other medicines and that each patient responds differently to a coronavirus infection.
Regeneron is a US biotechnology company and has been producing drugs of various types for more than thirty years, with particular attention to research related to the immune system. Its researchers have recently developed REGN-COV2, a “cocktail of artificial antibodies” (monoclonal antibodies) designed to bind to specific proteins of the coronavirus envelope, so that they cannot bind to the membranes of cells that are then exploited by the virus to replicate.
Development of the experimental drug began last February, shortly after the first news of the spread of the coronavirus beyond China. Over the summer, Regeneron received $ 450 million in funding from the US government as part of the initiative Warp Speed, dedicated to accelerating the development of pandemic vaccines and drugs. The pharmaceutical company is betting a lot on its cocktail and has also made a preliminary agreement with Roche, another large multinational drug company, with which to collaborate for the distribution of doses if and when they are approved for their marketing.
REGN-COV2 is in fact still in a first phase of experimentation, dedicated to verifying its safety even before its effectiveness. The details on the clinical tests carried out so far are not many: in a press release released last week, Regeneron announced that a trial on 275 individuals with COVID-19, but without symptoms requiring hospitalization, had shown a reduction in viral load and disease-associated disorders after receiving a dose of the monoclonal antibodies.
A MESSAGE FROM THE PRESIDENT! pic.twitter.com/uhLIcknAjT
— Donald J. Trump (@realDonaldTrump) October 7, 2020
The most significant improvements were seen in patients who did not develop an adequate immune response to the coronavirus. Also according to Regeneron, the drug had reduced the need to undergo medical examinations during the period of the disease, in patients who did not show the need for hospitalization from the first symptoms.
It therefore seems that the first results of REGN-COV2 are positive, but it is good to remember that the company has communicated the results through press releases, while more extensive and above all independently verified research is still missing. More months of clinical trials will be needed, on a larger number of patients, before obtaining any approval from the drug authorities.
For these reasons, for now, REGN-COV2 is not used in hospitals, unless it is allowed to use it as a “compassionate care” by the Food and Drug Administration (FDA), the US federal agency that deals with the safety of medications. In Trump’s case, this possibility was granted and a dose of the investigational drug was administered. Regeneron said it has so far provided its monoclonal antibodies in a dozen cases, for as many patients for whom other therapies had not proved effective: it is not clear how many of these have benefited from the experimental drug.
Announcing that he felt better in a few days, Trump also hinted that there are “hundreds of thousands” of doses ready. In fact, Regeneron has announced that it has produced them for about 50 thousand patients, but that could reach six times as much within a few months.
Taking advantage of the visibility gained after Trump’s improved conditions, Regeneron applied to the FDA to obtain emergency clearance for his drug, so that it can be used more extensively in hospitals before clinical trials are over.
However, experts and observers have expressed their skepticism about this eventuality, because REGN-COV2 is still in an initial state of experimentation and its use on a large scale, and in conditions that cannot be controlled as much as in a clinical trial, it could prove to be more risky than useful, not yet knowing all the potential adverse effects of treatment.
To date, there are also no elements to say with certainty whether it was the REGN-COV2 that made Trump’s conditions improve. In fact, before and during his short hospitalization he received different types of drugs, including Remdesivir, an antiviral drug that is administered to counter the replication of the coronavirus in the body. Trump was also given the dexamethasone, a steroid anti-inflammatory drug that has shown promise in severe cases of COVID-19, while it has shown less efficacy in reducing the risks of worsening in patients with milder symptoms.
The doctors who followed Trump provided rather incomplete information both during and after hospitalization, and there are therefore no details to get a better idea of the severity of the symptoms he had and his convalescence. Even in the presence of this information, it would still be difficult to establish whether the improvements were determined by the monoclonal antibodies of Regeneron or not: for this reason, clinical tests are conducted and protocols for the approval of new drugs are provided.