The supplement, known as ArtemiC, comes in the form of an oral spray and contains four key ingredients, namely curcumin (20mg/ml), vitamin C (60mg/ml), Boswellia serrata (15mg/ml) and artemisinin (6mg/ml),
It is undergoing product registration for sale in in Slovenia – also the country where the product is manufactured – and the company hopes that the supplement will be available as a supplement in the market this month.
At the same time, there are plans to launch the supplement in other parts of Asia, Roby Zomer, co-founder and MD at MGC Pharma told NutraIngredients-Asia.
“We see any place that has chance for COVID-19 or any other viruses, such as flu-type of viruses to spread, as a target for the product, and of course, Asia is a very unique and interesting market for us,” Zomer said.
The company is also in the progress of completing its phase IIa trial of using ArtemiC on COVID-19 patients.
The two-week human clinical trial, taking place in Israel and in India, will recruit 50 subjects.
Zomer emphasised that the purpose of the supplement was not to cure COVID-19 but to reduce the symptoms of the disease, such as lung failure and pain, in high-risk patients who are also suffering from diabetes and other lung diseases. The company plans to provide the trial results in October or November.
The long-term goal, according to Zomer, is to launch ArtemiC as a pharmaceutical product.
“When we see the benefits of it, we will try to make it more as a medicine, it is where our key knowledge is,” he said, adding there were plans to make it into a medicine by using a drug or active carrier that increases the bioavailability of the active ingredients.
The registration of the formula as a medicine will be subjected to the successful completion of the current trial. The company has already identified Russia as the market where it hopes to register the formula as a medicine.
Due to the current COVID-19 pandemic, the registration process of new medicines, which usually takes five to eight years, could be fast-tracked and shortened to nine to 12 months.
Interim trial results
The company last month announced that ArtemiC had met the primary objectives of the trial based on the results seen in 10 patients.
In the double-blind placebo-controlled clinical trial, seven were randomised into the intervention group. As part of the study, they had to apply the ArtemiC spray two times a day. The remaining three subjects went to the placebo group.
Results showed that the experiment group had better clinical outcomes when compared to the placebo.
For instance, in terms of the incidence of ICU stay, one patient from the placebo group was transferred to the ICU on day 13 of the two-week trial, while no patient from the intervention group was transferred to the ICU.
The researchers also measured improvements in the clinical outcomes based on the National Early Warning Score (NEWS2).
NEWS2 determines the degree of illness of a patient by measuring six physiological parameters. They are the respiration rate, oxygen saturation, systolic blood pressure, pulse rate, the level of consciousness, and temperature. A score of two or lower is the key goal of the research.
The subjects have NEWS2 baseline ranging from two to 12 when they were first admitted.
By the time they were discharged, all from the experiment group had a score of zero.
The placebo group also had two patients who had a score of zero, while the 3rd patient from the group had a score of 16.
There was also no adverse reaction observed towards the supplement, said the company.
Once the phase IIa trial is completed, the company plans to conduct a phase IIb trial in December.