Known as ArtemiC, the new product is jointly developed by MGC and Switzerland firm Micelle Technology based on a product originally developed by the latter. New adaptations have been made to the product in response to COVID-19.
The supplement, which also contains vitamin C and Boswellia serrata, will be tested on COVID-19 patients in Israel’s Nazareth Hospital EMMS.
The double-blind, placebo-controlled, two-week clinical trial will start in this month and aims to recruit 50 patients between 40 and 75 years old.
Concluding in September, the trial will assess the safety and efficacy of the supplement, with results available in October.
Some of the outcomes measured include the time to achieve a negative COVID-19 test result based on PCR, the incidence of ICU stay, as well as the incidence and duration of mechanical ventilation, MGC said in a statement.
This is one of the latest clinical trials involving the use of a dietary supplement or food on COVID-19 patients. Recently, we reported on clinical trials that assess the effectiveness of honey, omega-3, and other health foods on COVID-19 patients’ recovery.
Containing 20mg/ml of curcumin and 6mg/ml of artemisinin, the oral spray has been designed to target viral infections with inflammatory complications.
Curcumin is well-known for its anti-inflammatory effects while artemisinin is a botanical listed in the Chinese herbal pharmacopeia. It also gained prominence as an anti-malaria agent in the 1970s.
The company also told us that the bioactives used were all naturally-made and that the artemisinin used is naturally-derived from the artemisia annua plant.
Citing the animal studies by Cao and et al, the firm added that artemisinin have shown to inhibit the expression and release of pro-inflammatory cytokines in the lung tissues of rats suffering from lung injury.
“ArtemiC is a micellar formulation comprising two tested active ingredients, artemisinin and curcumin. These ingredients possess antiviral, antioxidant and anti-inflammatory activities relevant to multiple aspects of the pathophysiology associated with COVID- 19.
“This proposal identifies an emergency need for fast tracked clinical studies to address the medical challenges presented by COVID-19,” said Dr Jonathan Grunfeld and Dr Nadya Lisovoder who are both leading MGC’s clinical advisory team.
According to MGC, the supplement will be made and packed in its facility located in Slovenia.
Technology
The supplement has been formulated in nano-sized micelles.
This increases the bioavailability of curcumin and artemisinin, which are otherwise poorly soluble in water.
“In addition, micellar structures have noted to have improved access to the sites of inflammation associated with increased permeability as expected in conditions of acute lung injury of the nature encountered in COVID-19 pneumonia,” the firm said.
What’s next
Following a successful clinical outcome, MGC said it would consider going ahead with additional clinical trials.
The ultimate goal is to achieve full marketing authorisation of the product in relation to COVID-19 health claims based on successful clinical evidence.
If unsuccessful, the company would assess if there is still a need to proceed with further testing.
