In the absence of confirmation of the results in the last phase of clinical trials, Aplidin, a anticancer drug based on plitidepsin molecule could become the first drug with a proven effectiveness in reducing viral load in the first week of Covid-19 infection.
Between 80% and 90% of the 24 patients hospitalized for Covid who participated in phase 2 of the clinical trials, carried out in 13 Spanish hospitals, were discharged in the first 14 days and 37% obtained it before the Eighth day, as reported by the researchers participating in the study at a press conference on Tuesday.
“The experience has been in the entire cast of patients that we can find in this disease,” asserted José Barberán, specialist in Infectious Diseases at HM Hospital Montepríncipe. “The evolution has been magnificent, no patient has died, practically all have been discharged “.
The Minister of Health of the Community of Madrid, Enrique Ruiz Escudero, has accompanied the researchers and has shown hope that in “a not too distant future” there could be “an effective treatment against the disease.”
Effective in the first week
Plitidepsin, administered orally for three consecutive days, has been shown to be effective during the first phase of the disease, in which viral replication occurs.
In this way, and provided that the results are confirmed in the last phase of clinical trials, the drug would become a complement to corticosteroids such as dexamethasone, proven effective in the second week of severe infection, when the inflammation caused by the uncontrolled response of the immune system itself.
“You have to choose the patient well and you have to choose him early,” said Pedro Landete, pulmonologist at La Princesa. “Viral replication in these patients drops dramatically, and especially how much more at the beginning of the symptoms we give this treatment “.
The research team of the study promoted by the Spanish biopharmaceutical company PharmaMar is now awaiting authorization from the Spanish Medicines Agency to be able to start with phase 3 and they were convinced that the results will also be positive in these tests.
“Very promising” results
Vicente Estrada, an internist at the San Carlos Clinical Hospital in Madrid, has considered that, although it is “preliminary data”, since the objective of the trial was to analyze the safety and efficacy of the drug, the results of the study are “very promising” .
The clinical director of Pharmamar, José Jimeno, has said that, after verifying the “positive results” of the drug, the main objective of the company now is to request the regulatory agencies the necessary permission to launch a Phase 3 trial “as soon as possible”.
For that, in the coming weeks, Pharmamar will discuss “in a linear, honest, ethical and direct way” with regulatory agencies, such as the Spanish Medicines Agency and the US FDA, so that a trial with more patients is approved that allows comparison the drug’s results with current coronavirus treatments.