Life Science Alliance journal publishes results of plitidepsin in patients with COVID-19, which includes additional data on its antiviral activity against Delta and Omicron variants

Rhea-AI Summary

PharmaMar (MSE: PHM) announced the publication of a study in the Life Science Alliance journal on plitidepsin's efficacy against COVID-19. The research indicates that plitidepsin exhibits potent antiviral activity against SARS-CoV-2 variants, including Omicron, at low concentrations. In vivo studies showed a 99% reduction in viral loads in treated animals. The Phase I-II APLICOV-PC trial, involving 45 patients, confirmed safety and clinical efficacy, with 74% of moderate disease patients discharged within a week. These findings support the ongoing Phase III NEPTUNO trial in 17 hospitals across Europe and Latin America.

Positive

• Potent antiviral activity of plitidepsin against SARS-CoV-2 variants demonstrated.
• 99% reduction in viral loads in preclinical studies.
• Phase I-II APLICOV-PC trial met primary safety endpoints and showed clinical efficacy.
• 74% of moderate patients discharged within the first week of treatment.

Negative

• None.

MADRID, Jan. 11, 2022 /PRNewswire/ -- PharmaMar (MSE: PHM) has announced today the publication of an article in the Life Science Alliance journal, entitled "Pre-clinical and randomized phase I studies of plitidepsin in adults hospitalized with COVID-19"[1] which includes a study on the in vitro activity of plitidepsin against the main SARS-CoV-2 variants, including the current Omicron variant.

According to the final data published in this article, 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. These 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, N.Y., USA.

Laboratory in vivo studies have also demonstrated a preferential distribution of plitidepsin to lung tissue, which is the organ primarily affected in patients with COVID-19. These studies showed a reduction in viral replication, resulting in a 99% decrease in viral loads in the lung of plitidepsin-treated animals.

The article also reviews data from the APLICOV-PC clinical trial, which demonstrated the safety of plitidepsin in patients with COVID-19 requiring hospital admission. The trial met the primary safety endpoint and showed clinical efficacy; in addition the study gathered consistent evidence of a plitidepsin mediated impact on viral load, on inflammatory pathways and on lymphopenia normalization.

In this Phase I-II study, 45 patients were enrolled, of whom 86.7% had moderate or severe disease. 41 patients (91%) had pneumonia, 32 (71% of the global sample) of them with bilateral pneumonia. Of note were the data observed in 23 patients with moderate disease, 74% of whom were discharged from hospital within the first week of treatment.

These results are the basis for the Phase III NEPTUNO clinical trial that is currently recruiting patients in 17 hospitals in Spain and 9 other countries mainly in Europe and Latin America.

José F. Varona, M.D., Ph.D., at the Department of Internal Medicine, Hospital Universitario HM Montepríncipe in Madrid has highlighted "our clinical impression with plitidepsin in the APLICOV-PC trial has been met, since in addition to satisfactorily meeting the safety objectives, we have observed in some cases an improvement in symptoms and objective data (microbiological parameters, oximetry parameters and radiological parameters) after administration of the drug."

Adolfo García-Sastre, Ph.D., professor at the Department of Microbiology at the Icahn School of Medicine at Mount Sinai, New York, commented, "It is noteworthy that the clinical data are consistent with the preclinical data, suggesting a benefit of plitidepsin administration to patients with COVID-19, and that, in pre-clinical models, plitidepsin has potent antiviral activity, not only for SARS-CoV-2 and its variants, including Delta and Omicron, but also against other coronaviruses."

José María Fernández Sousa-Faro, Ph.D., PharmaMar's Chairman stated "all the data we have seen so far with plitidepsin corroborate our initial hypothesis about its antiviral activity. In studies conducted both by PharmaMar and leading researchers from around the world, plitidepsin has demonstrated previously unseen potency against SARS-CoV-2. We hope that patient recruitment for the NEPTUNO trial will continue to progress, so that we can bring this treatment to all patients affected by the coronavirus and requiring hospitalization, as soon as possible. "

[1] https://www.life-science-alliance.org/content/5/4/e202101200

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SOURCE PharmaMar

FAQ

What did PharmaMar announce on January 11, 2022 regarding plitidepsin?

PharmaMar announced the publication of a study showing plitidepsin's potent antiviral activity against COVID-19 variants in the Life Science Alliance journal.

How effective is plitidepsin against COVID-19 variants according to the study?

The study found that plitidepsin has potent antiviral activity against SARS-CoV-2 variants, including Omicron, at low concentrations.

What were the results of the APLICOV-PC clinical trial for plitidepsin?

The APLICOV-PC trial demonstrated safety and clinical efficacy, with 74% of patients with moderate disease discharged within a week.

What is the next step for the plitidepsin treatment after the initial trials?

The findings support the ongoing Phase III NEPTUNO clinical trial, which is recruiting patients across Europe and Latin America.

What significant reduction in viral loads was observed during the preclinical studies of plitidepsin?

Preclinical studies showed a 99% decrease in viral loads in the lungs of plitidepsin-treated animals.