The company PharmaMar has announced this Tuesday the publication of a study on the activity in vitro from I applauded, a drug in development against Covid-19 whose active principle, the plitidepsin, confirms its efficacy against the main variants of SARS-CoV-2, including the current Omicron and Delta.
Laboratory studies in vivo have also shown a preferential distribution of plitidepsin towards lung tissue, which is the fundamentally affected organ in patients with Covid-19. In these studies, a reduction in viral replication was observed, resulting in a 99% decrease in viral loads in the lung of animals treated with plitidepsin.
The article, published in the magazine Life Science Alliance, shows that plitidepsin has been shown to have powerful antiviral activity in all variants at very low concentrations (nanomolar) with a positive in vitro therapeutic index. These studies have been led by Dr. Adolfo García-Sastre, Professor in the Department of Microbiology at the Icahn Mount Sinai School of Medicine, New York, United States.
“It should be noted that the clinical data correspond to the preclinical ones, suggesting a benefit in the administration of plitidepsin to patients with Covid-19, and that, in preclinical models, plitidepsin has potent antiviral activity not only against SARS-CoV-2 and its variants, including delta and omicron, but also against other coronaviruses “, emphasizes García-Sastre.
Likewise, the article reviews the data from the APLICOV-PC1 clinical trial, in which the safety of plitidepsin was demonstrated in patients with Covid-19 who require hospital admission. The trial achieved the primary safety endpoint and showed clinical efficacy. In addition, the study gathers consistent evidence of a plitidepsin-mediated impact on viral load, in inflammatory pathways and in the normalization of linfopenia.
In this phase I-II study, 45 patients, of which 86.7% had moderate or severe disease. 41 patients (91%) had pneumonia, of which 32 (71% of the global sample) had bilateral pneumonia. The data observed in 23 patients with moderate disease stand out, of which 74% were discharged from hospital in the first week of treatment.
These results support the Phase III NEPTUNO2 clinical trial, which is currently recruiting patients in 17 hospitals in Spain and in 9 other countries, mainly in Europe and America.
“Our clinical impression with plitidepsin in the APLICOV-PC study has been fulfilled, since in addition to satisfactorily reaching the safety objectives, we have objectified in some cases rapid improvement of symptoms and objective data (microbiological parameters, oximetry parameters and radiological parameters) after drug administration “, says José F. Varona, physician from the Department of Internal Medicine, HM Montepríncipe University Hospital in Madrid.
José María Fernández Sousa, President of PharmaMar and professor in Biochemistry at the Complutense and Santiago de Compostela Universities, highlights for his part that “all the data that we have seen so far with plitidepsin corroborate our initial hypothesis about its activity as an antiviral”.
“In the studies carried out by PharmaMar as well as by world-class researchers around the world, plitidepsin has been shown to have unprecedented potency against SARS-CoV-2. We hope that the recruitment of patients from the NEPTUNO trial will continue to advance. to be able to bring this treatment as soon as possible to all patients affected by the coronavirus and who require hospital admission, “” he concludes.