PharmaMar (MSE:PHM) on Tuesday announced the publication of an article entitled "Pre-clinical and randomized phase I studies of plitidepsin in adults hospitalized with COVID-19" against the against the main SARS-CoV-2 variants, including Omicron variant, in the Life Science Alliance journal, co-founded by the Rockefeller University, the European Molecular Biology Organization and Cold Spring Harbor Laboratory.
Based on the final data published in this article, the company said the plitidepsin has been shown to have a potent antiviral activity in all variants at very low (nanomolar) concentrations, with a positive in vitro therapeutic index. The studies were led by Dr Adolfo Garcia-Sastre, Professor in the Department of Microbiology at the Icahn School of Medicine at Mount Sinai, New York, NY, USA.
The laboratory in vivo studies demonstrated a preferential distribution of the company's plitidepsin to lung tissue, which is affected in patients with COVID-19. There was a reduction in viral replication, with 99% decrease in viral loads in lung of plitidepsin-treated animals.
In addition, the article reviews data from the APLICOV-PC clinical trial, which demonstrated the safety of the company's plitidepsin in patients with COVID-19 requiring hospital admission. The trial met the primary safety endpoint and showed clinical efficacy. The study gathered consistent evidence of a plitidepsin mediated impact on viral load, on inflammatory pathways and on lymphopenia normalization.
The data was observed in 23 patients with moderate disease, 74% of whom were discharged within first week of treatment. The results are the basis for Phase III NEPTUNO clinical trial that is currently recruiting patients in Europe and Latin America, concluded the company.
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