The company, which is behind the PEA ingredient trademarked Levagen+, has concluded studies assessing the effectiveness of Levagen+ against the COVID-19 virus via in-silico and in-vitro studies.
A human clinical study conducted on COVID-19 patients was also completed in the US.
“What's interesting is that what we saw in-silico, in computer modelling was validated in the in-vitro setting, and was later validated in humans, which showed a very strong basis of the mode of action, as well as the efficacy.
“What we have found in our human clinical trial is that the inflammatory markers related to forming blood aggregation leading to blood clots were controlled, and also, the overactive immune system was controlled in the COVID-19 positive patients, as compared to placebo,” Ramasamy Venkatesh, CEO of Gencor, told NutraIngredients-Asia.
Findings of the in-silico and in-vitro studies were recently published in Viruses, while that of the clinical trial is expected to be published in Q3.
According to the findings published on Viruses, PEA works against COVID-19 via two mechanisms.
First, its binding to the COVID-19 spike protein causes a drop in viral infection of approximately 70 per cent.
Second, it was shown that treatment with PEA dismantles lipid droplets in infected cells. This action prevents the COVID-19 virus from using the lipids as a source of energy and protection.
"The antiviral role of PEA was tested on both viral entry and replication. Indeed, PEA might exert a dual antiviral activity by binding to the SARS-CoV-2 S protein and activating PPAR-α signaling, which, once active, dismantles intracellular lipid droplets (LDs), the very same vesicles that have recently been suggested to boost SARS-CoV-2 replication," the researchers said in the paper.
Venkatesh explained that the firm studied PEA and its effects against COVID-19 as there were existing information on how the antiviral ingredient was effective against the common cold and flu viruses.
“There has been published clinical studies way back in 1930, showing PEA’s antiviral properties against the cold and flu viruses.
“It showed good efficacy against the symptomatic relief of flu virus, as well as a prophylactic activity in preventing the onset as well as reducing symptoms of cold and flu viruses,” he said, citing the findings of studies conducted in the former Czechoslovakia.
Human clinical trial
The human clinical trial involved 60 COVID-19 patients, with half of them taking Levagen+ and the other half taking a placebo.
The study was conducted in collaboration with Arizona State University.
“We received ethics approval from the university to start the study during November 2020. We then started the study in end 2020, when the COVID-19 vaccines were not ready yet. The study was completed in the middle of last year.
“The results have come out well, they sort of corroborate what was seen in our previous studies in terms of mechanism of action, and we are seeing positive effects on the control of inflammatory markers in COVID-19 positive patients.
“The paper is currently under peer review with leading journals for publication. We hope that it will get published during quarter three.”
With the findings, the firm’s plan is to introduce the ingredient for use as an adjuvant product in COVID-19 treatment and as health supplements for maintaining adequate immunity, Venkatesh said.
Palmitoylethanolamide (PEA) Inhibits SARS-CoV-2 Entry by Interacting with S Protein and ACE-2 Receptor
Authors: Fonnesu R et al