The trial is expected to take place in the second half of this year, which coincides with the winter season in Australia.
“SARS, MERS, swine flu, and the current coronavirus…These kinds of virus infections which are closely related to flu are not going to go away,” the company’s CEO, R. V. Venkatesh told NutraIngredients-Asia.
“The current situation shows that there is a very huge need to conduct research in this the area of immune boosting ingredients, not only with PEA, but also the other ingredients,” he said, giving the examples of elderberry, vitaminc C, and beta-glucan.
The human trial will add onto the existing research that the company has conducted on PEA, including its benefits for anti-inflammatory, muscle recovery, joint pain, and sleep.
He added that Australia was the prime option because by the time the trial started, it would already have been winter in the region and that would also be the period when the number of infected cases would peaked.
The company is firming up the study design and will embark on the trial once it has obtained approval from the ethics committee.
Mechanisms
The trial will study the impact of PEA on the symptomatic relief of flu symptoms and its ability to boost the immune system.
PEA is an endogenous endocannabinoid receptor agonist. Existing literature has shown that the PEA, which exerts anti-inflammatory and painkiller abilities, does so by preventing mast cells degranulation.
“One of the key mechanisms of PEA is to prevent mast cells degranulation. The mast cells contain all the inflammatory cytokines as well as other pro-inflammatory compounds.
“It is also a key factor when it comes to areas such as allergy and cold relief, because people who are having cough, flu, body pains, have inflammation as well,” Venkatesh said.
Citing the findings of a 2013 study, he said it showed the potential mechanisms on how PEA works, which would be key in the company’s upcoming trial design.
The study, conducted by Hesselink et al, reviewed the role of PEA as a therapeutic agent for influenza and the common cold from six clinical trials involving nearly 4,000 patients.
It concluded that PEA should be reconsidered by clinicians “as a new treatment modality for the flu and respiratory infections due to its documented efficacy,” especially in light of resistance against conventional flu medications – the oseltamivir and zanamivir.
Practising responsibility
Amid the epidemic, there has been companies which claimed that their products could guard against the coronavirus.
Venkatesh said it was important to practice responsibility when it came to making product claims.
He emphasised that the company’s intention was to develop a nutraceutical product for symptomatic relief of flu and boosting the immunity – not to be confused with a pharma product for treating the coronavirus.
“Right now, there are a lot of people making a lot of claims about miracle cures for flu and the coronavirus, and the regulatory authorities also do not like it, because there is no evidence that anything is working against the coronavirus.
“That is why we want to be careful and not to be mistaken.”
