PharmaMar announces results of its APLICOVPC study in adult patients with COVID-19 requiring hospital admission

The trial has met the primary safety endpoint. Of note are the results obtained in patients with moderate disease, 74% of whom were discharged from hospital during the first week of treatment. Based on the data obtained from this study, the Phase III NEPTUNO study has been launched and will determine the efficacy of plitidepsin for the treatment of hospitalized patients with moderate COVID-19. The full data document is available at -> Medrxiv.org PharmaMar (MSE:PHM) has announced today the final results of its APLICOV-PC clinical trial with Aplidin® (plitidepsin) for the treatment of adult patients with COVID-19 requiring hospitalization, which met the primary safety endpoint and showed clinical efficacy. In view of the start of the Phase III NEPTUNO trial, the Company has decided to share this data, which demonstrates the therapeutic potential of this drug with the entire scientific and medical communities, along with patients. We have chosen to anticipate the information in a previous paper, entitled “Plitidepsin has a positive therapeutic index in adult patients with COVID -19 requiring hospitalization“, which shows the work of preclinical and clinical multidisciplinary teams on the management of plitidepsin as an antiviral. Full data can be found at: https://www.medrxiv.org/content/10.1101/2021.05.25.21257505v1 The APLICOV-PC study evaluated three cohorts of hospitalized patients with mild, moderate or severe disease3, with three different dose levels of plitidepsin (1.5mg – 2.0mg – 2.5mg), administered on three consecutive days. Of the 45 patients treated in the trial, 86.7% had moderate or severe disease. 91% had pneumonia, with 71% having bilateral pneumonia. In the results obtained in this study, the data observed in 23 patients with moderat e disease stand out, 74% were discharged from hospital in the first week of treatment. As can be seen in the graph of patients admitted with moderate COVID-19, those who received the 2.5 mg dose were most likely to be discharged during the first weekof hospitalization. In this same group of patients, it has been observed that the higher the dose of plitidepsin, the higher the lymphocyte count over time, an indicator of improvement of the immune system. Likewise, a parallelism is observed between the decrease in viral load, clinical improvement and the fall in inflammation parameters, such as Creactive Protein. This suggests that, in addition to its antiviral effect, plitidepsin could be exerting anti-inflammatory effects, favoring the immune response against SARSCoV-2. This publication also reaffirms the initial hypotheses on the transversality of plitidepsin against other strains or variants of coronavirus, since it acts by blocking the eEF1A protein, present in human cells, which is used by different types of coronavirus to reproduce and infect other cells. The data obtained in this study have led the Company to launch the new Phase III NEPTUNO study, which will determine the efficacy of plitidepsin for the treatment of hospitalized patients with moderate COVID-19 infection. It is worth mentioning the opinion of the researchers and doctors who have made this research possible. Pablo Guisado Vasco, M.D., Ph.D., Consultant Internal Medicine at Hospital Universitario Quirónsalud Madrid, concludes: “We still need effective drugs against COVID-19. Plitidepsin is a very promising compound with a solid preclinical development. It has completed the Phase I/II study with good safety and early clinical data demonstrating an adequate efficacy in moderate COVID-19 pneumonia. In the coming weeks, with the opening of recruitment for the NEPTUNO trial and a head-tohead comparator group, we will be able to know more precisely what the clinical role and efficacy of plitidepsin in COVID-19 is.” José F. Varona, M.D., Ph.D., physician at the Department of Internal Medicine, Hospital Universitario HM Montepríncipe in Madrid has highlighted “the positive results of plitidepsin in the APLICOV-PC clinical trial, both in terms of safety and efficacy, are very encouraging news for the therapeutic management of COVID-19 pneumonia requiring hospital admission,” and adds: “in this regard, we must highlight both its specific mechanism of action, which gives added value against the different variants of SARS-CoV-2, and its good safety profile, with excellent tolerability.” Vicente Estrada, M.D., Head of the Infectious Diseases Unit at the Hospital Clínic o San Carlos in Madrid, said: “plitidepsin has a very potent antiviral action in vitro and in the APLICOV-PC trial the drug showed sufficient safety, with few adverse effects, mostly gastrointestinal and largely controllable with premedication. In the future, if the results of the NEPTUNO study are favorable, plitidepsin could be used in the early treatment of this disease in patients with a respiratory compromise.” Regarding the results obtained in this study, Luis Enjuanes, Ph.D., Director of the coronavirus group at the National Center of Biotechnology of the CSIC, said: “In our laboratory at the National Center of Biotechnology (CNB-CSIC), we have evaluated the effect of plitidepsin by observing a thousand-fold inhibition, using doses of the drug that were not toxic when administered to patients. These results were later significantly reinforced at Prof. Adolfo García Sastre laboratory (Mount Sinai School of Medicine, New York), who compared the effect of plitidepsin with those of Remdesivir, the most widely used antiviral in the United States against SARS-CoV2.” Adolfo García-Sastre, Ph.D., Professor at the Department of Microbiology and Director of the Global Health Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, USA, and co-author of the publication, comments: “the collaboration between several basic , applied and clinic al research groups working in different academic and pharmaceutical institutions highlights the potential of plitidepsin as a possible treatment for coronavirus infections, including SARS-CoV2.” We would like to take this opportunity to extend our sincerest gratitude to the patients, their families and caregivers, as well as the dedicated medical teams and hospital staff who participated in the clinical trial and helped plitidepsin reach this point.

The release as fetched from its publisher. pharmamar.com ↗