Octofene, is an antibiotic in suppository form that has long been prescribed to treat certain bacterial respiratory infections. Will this drug be the long-awaited treatment to limit severe forms of covid-19? This is what researchers at the Institut Pasteur de Lille are hoping for, who have been studying the repositioning of this molecule for several months as part of their Therapide project.
This June 6, the‘Institut Pasteur de Lille announces the recruitment of the first patient in its phase 2/3 clinical trial aiming to measure the effectiveness of clofoctol in the early management of COVID patients and the prevention of hospitalization.
“We are optimistic that the phase 2/3 trial will provide important elements relating to the usefulness of clofoctol in the treatment of the early stages of COVID19 and the prevention of hospitalization of treated patients”, reports Benoît Déprez, project manager and scientific director of the Institut Pasteur de Lille. However, recruiting unvaccinated patients from an 80% vaccine population may take time, making the trial “very difficult”, comment Xavier Nassif, director of the institute for the Journal du Dimanche on September 5.
In order to be able to quickly launch clinical trials, the Institut Pasteur de Lille had requested the National Steering Committee for Therapeutic Trials (CAPNET) which issues the “National Research Priority” labels to studies with a high potential impact. A label which had been granted to him on April 7 in order to quickly include the first patients in the Therapide project and to measure the tolerance and effectiveness of the treatment on Covid-19.
First tests in 5 centers
Since April, the procedure has followed its course and this time it is the National Medicines Safety Agency (ANSM) which has just granted its authorization to this project. The clinical trial will therefore be able to start today, with patients having the following profile:
- be over 50,
- have at least one symptom,
- have had a recent positive test,
- not have been vaccinated.
This Monday June 14, 5 clinical trial centers have been opened in the following localities: Senlis, Maubeuge, Château-Thierry and Lille. From June 21, other centers will be open, still in Hauts-de-France. A map of the localities in which the trial is active will be published and regularly updated.
What drug is tested?
From the start of the Covid-19 health crisis, in March 2020, a research team bringing together researchers from several laboratories of the Institut Pasteur de Lille (CNRS, Inserm, Université De Lille, CHU de Lille and the start-up Apteeus specialized in the repositioning of drugs) has mobilized in the search for a treatment against Covid-19. They are using a base of 2000 molecules already used for other diseases in order to identify those which could be able to provide an effective response against the virus. The objective was to search this “chemical library” for an effective drug against Covid-19.
“And in early summer 2020, one of them, the clofoctol (the medicine is called Octofen) has been shown to be particularly potent against the virus and has since been the subject of a series of trials. As this molecule already has a marketing authorization for respiratory infections, the protocol allowed a faster delay in its implementation ” explains the Institut Pasteur de Lille.
A drug that prevents contagion
To avoid a “hydroxychloroquine” effect, researchers have long preferred to keep the name of this molecule silent. We have known for some time that this is clofoctol, prescribed in France from 1978 to 2005 to treat mild respiratory infections in the form of Octofen suppository. If it had been withdrawn from the market in 2005, it is because this antibiotic was no longer considered useful, because nasopharyngitis could heal on its own.
“This molecule has an action on the two entry points of the virus in human cells, unlike hydroxychloroquine. In addition, it is not necessary to increase its concentration for it to be effective, unlike Remdesivir “, specifies Benoît Déprez scientific director of the Institut Pasteur in Lille. “We have proven that its active principle can kill the virus at a concentration thirty times lower than that which is basically proposed …” he adds.
“Taken at the first symptoms of the disease, this drug reduces the viral load of the carrier of the disease, prevents contagion. Taken later, it thwarts its severe forms. Its action is that of an antiviral and not that of an anti-inflammatory“explains Professor Déprez.
A donation of 5 million euros to launch the clinical trial
This molecule is, for the moment, the only one which is positioned on the beginning of the disease. But we must now prove its effectiveness on humans. “We are going to conduct an extremely rigorous clinical trial, respecting all the stages of the procedure” explains the Institut Pasteur. To carry out this clinical trial, the Institute had launched an appeal for donations because it had need 5 million euros. This appeal was heard by the LVMH group and Bernard Arnault, who had contacted the research establishment “from the announcement of its first results on this work”.
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