The interim results of a Phase 2 Clinical Trial, which was performed on COVID-19 patients at the Hillel Yaffe Hospital in Hadera and the Scottish Hospital in Nazareth, show that patients who had taken the supplement ArtemiC do not suffer from the disease’s complications, including the pain and physical damage that characterize COVID-19.
In comparison, the control group that did not receive the supplement is suffering from exacerbation of symptoms in the respiratory system, up to the point of requiring ventilation, pains, and the absence of any improvement in the disease's symptoms.
ArtemiC is composed of natural ingredients and is still in the registration process as a drug. However, it has already been approved for sale as a food supplement.
The interim results of the Phase II double-blind placebo-controlled clinical trial for anti-inflammatory treatment using ArtemiC in subjects diagnosed as COVID-19 patients have shown that it meets all its primary endpoints regarding safety and efficacy of the treatment in the first 10 patients who used it.
It is important to note that these interim results also meet the primary FDA endpoints of ongoing clinical improvement and a solution to the symptoms, and also prevention of the need for intensive care or invasive mechanical ventilation. This is in line with the FDA guidelines regarding inclusion of criteria for treating high-risk COVID-19 patients.
According to the study's interim results, inter alia, use of the supplement also prevented the need for anesthesia and ventilation in high-risk patients with a complex clinical history, such as renal diseases, diabetes, obesity, etc. It is important to note that patients who took ArtemiC did not suffer from any adverse effects whatsoever, which proves the safety of using it. ArtemiC is applied as a sublingual spray.
Together with the pre-clinical results, the interim results support the high probability of safety and efficacy of ArtemiC as treatment of COVID-19 symptoms. Currently, the Phase IIb clinical trial has commenced at the aforementioned two hospitals in order to continue testing the effect of ArtemiC and its ingredients - which include artemisinin, vitamin C, curcumin, and boswellia seratta - on 19 COVID-19 patients.
The various ingredients in ArtemiC have been scientifically proven as having a beneficial effect on the immune system, on anti-inflammatory activity, as an antioxidant, as an antibiotic, and even as an antiviral drug. The major impediment preventing clinical use of these active ingredients is derived from their inferior solubility in water, because of which they were not absorbed efficiently in the body. ArtemiC includes innovative technology that overcomes the solubility difficulty of these ingredients in water and enables their efficient absorption in the body to the degree that aids effective treatment.
All the information received from the interim analysis data from the Phase IIa trial will serve the company for planning the Phase IIb and Phase III clinical trials, pursuant to the defined procedures and endpoints based on the pre-clinical trials and the Phase IIa results. These interim results support MGC Pharma’s intended plan to develop a drug for COVID-19 patients.
Roby Zomer, an Israeli who serves as the co-founder and CEO of MGC Pharma, said: “We are very pleased with the Phase II interim results of ArtemiC, which, thus far, have met all the primary endpoints, while also demonstrating the safety of the treatment in human subjects.”
“These results, combined with our recent pre-clinical results, are important for designing the protocols and markers for our next Phase IIb clinical trial.”
Dr. Elias Hillou, a clinical trial investigator from the Hillel Yaffe Medical Center, said: “At our hospital, we have had much experience in treating COVID-19 patients, as one of the leading treatment hospitals in Israel.”
“However, unfortunately we had recurring disappointments with deterioration among the patients, with no tools at our disposal for treating this effectively. The interim analysis of this study has proven the safety and efficacy of ArtemiC in treating COVID-19 patients. We do not see any deterioration in the clinical condition in patients who received the supplement, compared with the placebo group in which there was massive deterioration with one patient who was in critical condition requiring ECMO. Our aim is to treat 50 patients according to the well-designed clinical protocol, hopefully to demonstrate the safety and efficacy of ArtemiC in the struggle against the COVID-19 virus and helping the effective treatment of infected patients.”
Dr. Nadya Lisovoder, CEO of “Galilee Clinical Bio Research Ltd,” who is managing the study, said: “We are very happy and proud to be a part of this important project, which has demonstrated that it has the potential to aid in the treatment of COVID-19-affected patients and that it has positive implications for managing the health system in the current global pandemic, with which we are dealing today.”
Eliron Yaron, CEO of Onassis Holdings, which is the authorized marketer of ArtemiC in Israel, the US, China, and Arab states, added: “According to a Gallup poll in the United States, one-third of Americans will refuse to be inoculated against COVID-19. Many do not trust a vaccine that has been developed quickly. Clearly, those people would prefer to use a supplement from a natural source that has been proven as being effective.”
“Currently, we are prepared to recruit additional investors and marketers throughout the world in order to deepen the marketing and distribution activity of the supplement. Currently, the supplement is available for immediate purchase from us, but the fact that some of the ingredients of the drug are produced from medicinal herbs that are difficult to obtain must be taken into account and, therefore, we cannot supply more than 1 million doses per month during the forthcoming period.”