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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Phone: +34 918466000
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SOURCE PharmaMar