Success in Clinical Study in COVID-19 Patients in Israel

YERUSHALAYIM -
The ArtemiC-MGC Pharma additive.

Interim results of the Phase 2 clinical study, performed at two hospitals in Israel, have disclosed that use of the innovative additive by COVID-19 patients results in a substantial alleviation of the symptoms and reduces the number of patients hospitalized at hospitals in view of severe physical effects, including respiratory difficulties. This supplement is in the registration process as a drug. Roby Zomer, an Israeli, who serves as a cofounder and CEO of MGC Pharma: “These results, combined with our recent preclinical results, are important for designing the protocols and markers for our next Phase IIb Clinical Trial.”

The interim results of the 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, called ArtemiC, which is composed of natural ingredients and which, while still in the registration process as a drug, has already been approved for sale as a food supplement, 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 in the respiratory system up to the point of requiring ventilation, pains and the absence of any improvement in the disease symptoms.

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 proven 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– Ongoing clinical improvement and a solution to the symptoms and also prevented 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 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 when using it. ArtemiC is applied as a sublingual spray.

Together with the preclinical 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 (that include Artemisinin, Vitamin C, Curcumin ad Boswellia Seratta) on 19 coronavirus 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 to preventing clinical use of these active ingredients 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 preclinical 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 cofounder and CEO of MGC Pharma, which is listed on the Australian Stock Exchange: “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 preclinical results, are important for designing the protocols and markers for our next Phase IIb Clinical Trial.”

Dr. Nadya Lisovoder, CEO of “Galilee Clinical Bio Research Ltd.,” who is managing the study: “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 U.S., China and Arab states, says: “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.”

ArtemiC is the result of development by the European bio pharma company, MGC Pharma, which develops and supplies affordable phytocannabinoid-based drug for patients throughout the world. The company founders were key figures in the global medical grade cannabis industry and their core business activity is to develop and supply high quality phytocannabinoid-based drugs pursuant to the growing demand in European, North American and Australian medical markets.