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Pharmaceutical company PharmaMar announced today that it has been approved by the UK Medicines and Medical Products Regulatory Authority (MHRA) to conduct a Phase III clinical trial of NEPTUNO, which aims to assess the effectiveness and safety of Plitidepsin's treatment of moderate COVID-19 inpatients.
Aptidepsin works by blocking the eEF1A protein present in human cells, which SARS-CoV-2 uses to replicate and infect other cells.
this block prevents the virus from multiplying in cells, making it unable to survive, and prevents it from spreading to other cells.
MHRA was the first regulator to authorize nePTUNO Phase III trials.
the design of the trial is based on the results of the APLICOV-PC trial in Phase I-II, which proves the safety and importance of the treatment of COVID-19 by Plitidepsin.
NEPTUNO Phase III trial will recruit more than 600 patients at about 70 centres in the UK, other European countries and other countries around the world.
the main purpose of this study was to compare the advantages of Aplidin (plitidepsin) at two dose levels (1.5 or 2.5 mg) over standard care.
endpoint indicator is the percentage of patients who fully recover on ± day (1).