Spanish regulators have given PharmaMar the green light to begin Phase 3 trial of a promising drug to treat COVID-19, the company announced on Thursday.
In lab tests, an international group of researchers found that the drug, plitidepsin, was 27.5 times more effective than the well-known remdesivir in limiting virus replication in human cells.
That research was published in the peer-reviewed Science journal.
Another of its potential strengths is that rather than attacking the virus itself, plitidepsin blocks a host protein that allows the virus to spread in the body.
“If plitidepsin is successful in the treatment of COVID-19, the SARS-CoV-2 virus will be unable to gain resistance against it through mutation, which is a major concern,” said Kris White of Mt. Sinai Medical school and first author of the Science paper, in a press release.
The Spanish pharmaceutical company Pharmamar said the drug has demonstrated a 99% reduction of viral loads in the lungs of plitidepsin-treated animals.
Pharmamar has also completed a successful Phase 1-2 trial on safety and efficacy, which has allowed them to expand to a larger clinical trial.
The company expects to enroll more than 600 patients around the world once it obtains all the necessary regulatory permissions.
The main goal of the new trial is to compare plitidepsin to the standard treatments of dexamethasone or dexamethasone combined with remdesivir in hospitalized patients with moderate COVID-19.
Its success will be judged by the number of patients who fully recover by day eight and who are not readmitted to the hospital in the following month.
The drug’s original compound was first discovered in rare sea creatures called sea squirts living in the waters of Ibiza. It is currently approved in Australia, under the name Aplidina, to treat blood cancer.
PharmaMar’s stock shot up by 7% on Thursday in response to the Phase 3 trial announcement.