PharmaMar has submitted a Phase II clinical trial of Aplidin® (plitidepsin) for the treatment of COVID-19 to the Spanish Medicines Agency
The objective of the trial is to evaluate the efficacy and safety of plitidepsin as a treatment for COVID-19 (SARS-CoV-2) in hospitalized patients.
Plitidepsin, which is approved in Australia for the treatment of multiple myeloma, has also demonstrated efficacy as an antiviral in in vitro studies conducted at the CSIC's National Biotechnology Center against the human coronavirus HCoV-229E, and previously against other types of virus at the Carlos III Health Institute.
Madrid, April 2nd, 2020. PharmaMar (MSE:PHM) has announced that on March 24th the APLICOV clinical trial protocol for Aplidin® (plitidepsin) was submitted to the Spanish Medicines and Healthcare Products Agency (AEMPS). This is a multicenter, randomized Phase II clinical trial, in which two different doses of plitidepsin will be evaluated for the treatment of patients with COVID-19 pneumonia. The protocol is currently being evaluated.
The protocol includes 160 patients admitted to hospitals in Spain, where it is intended to assess whether plitidepsin, administered intravenously for 5 days to patients with COVD-19 pneumonia, reduces the proportion of patients who progress to Acute Respiratory Distress Syndrome (ARDS), the main cause of patients requiring mechanical ventilation and/or admission to Intensive Care Units.
Several Spanish centers are due to participate in the study and which is expected to start as soon as the authorization from the Health Authorities is obtained.
On March 13th, the Company announced the results of in vitro studies of plitidepsin in human coronavirus HCoV-229E, with a mechanism of multiplication and propagation that is very similar to that of SARS-CoV-2. The studies were carried out at the National Biotechnology Centre of the Spanish National Research Council (CSIC) by Dr. Luis Enjuanes, Dr. Sonia Zúñiga and Dr. Isabel Solá (see press release).
According to José María Fernández, President of PharmaMar, "This health emergency requires us all to work together to stop this pandemic. Each of us is obliged to do our utmost". He added, "As soon as we receive authorization from the AEMPS, we will be able to start the clinical trial with plitidepsin and we hope that it can become an effective weapon against COVID-19".
Plitidepsin acts by blocking the protein eEF1A, present in human cells, which is used by SARS-CoV-2 to reproduce and infect other cells. By means of this blocking, the reproduction of the virus inside the cell is prevented, making its propagation to the rest of the organism’s cells, unfeasible.
