MGC Pharmaceuticals : ArtemiC Phase II Clinical Trial Results

15 December 2020

ASX Code: MXC

ArtemiCTM Phase II Clinical Trial Results on COVID-19 patients confirm 100% of treatment group successfully met primary and secondary endpoints

Key Highlights:

• Full results of MGC Pharma's phase II double blind clinical trial show ArtemiCTM has successfully met the primary and secondary study endpoints
• ArtemiCTM statistically significantly improved the clinical recovery of 50 COVID-19 infected patients in the treatment group in comparison with placebo.
• 100% of the patients in the treatment group met the Trial's primary end point and fully recovered within 15 days of follow up
• ArtemiCTM delivered a NEWS score (main parameter of clinical improvement in COVID-19 patients) of less than or equal to 2 in 100% of patients in the treatment group
• The Trial met all the FDA requirements for a COVID-19 study including population diversity
• None of the patients in the treatment group required additional oxygen, mechanical ventilation or admission to intensive care, in comparison with 23.4% of the placebo group requiring further assistance
• ArtemiCTM results deliver a full safety and efficacy profile, demonstrating to improve and expedite the clinical recovery in moderate COVID-19 patients
• Full Trial results are supported by in vitro and in vivo studies, demonstrating the mechanism of action and safety profile of ArtemiCTM
• These results now open potential market opportunities for ArtemiCTM to a wide range of diseases related to cytokine storm such as autoimmune diseases, inflammatory GI diseases, 'flu and chemotherapy patients
• Next steps for the product development will include immediate evaluation of a Phase III Trial in COVID-19 and 'flu patients and classification of ArtemiC™ under new name as IMP (Investigational Medicinal Product) which will be produced in MGC EU GMP facilities
• Following successful Phase III Trial results ArtemiCTM can be produced and sold by the Company as a supplement, through its existing production facilities and distribution networks

MGC Pharmaceuticals Ltd (ASX: MXC, 'MGC Pharma' or 'the Company'), a European based bio- pharma company specialising in the production and development of phytocannabinoid-derivedmedicines, is pleased to announce the full results of its Phase II double-blind, placebo-controlledclinical trial for anti-inflammatorytreatment ArtemiCTM, based on Swiss PharmaCan AG MyCell Enhanced™ delivery system technology ('MyCell™'), on persons diagnosed with COVID-19,has successfully met all the Phase II primary and secondary endpoints and demonstrated to improve the clinical recovery of COVID-19patients. The ("Trial").

Key Trial Results

The Company has completed its Trial on ArtemiCTM on 50 infected patients across 3 independent hospital sites in Israel and India, 50 patients were recruited to the trial, 33 in the treatment group and 17 in the placebo group.

The full results have demonstrated to improve the health status of COVID-19 patients delivering a NEWS score of less than or equal to 2. None of the patients in the treatment group required additional oxygen, mechanical ventilation or admission to intensive care where all of these events were reported in the placebo group. The average NEWS score of patients in the placebo group was 2.25 statistically significantly higher (p<0.04) than in the treatment group - 0.5.

No. of days

The improvement of NEWS in treatment group vs placebo group is demonstrated in Figure 1.

Figure 1. Daily improvement of NEWS parameter in both study groups, p<0.04

Additionally, ArtemiCTM demonstrates the following distinct advantages.

• A full safety and efficacy profile with no drug-adverse events
• The ability to prevent deterioration of COVID-19 patients and achieve faster clinical improvement
• The ability to assist in reducing the pressure on the medical system and support coping with hospitalised patients
• The ability to improve symptoms and pain associated with COVID-19
• The versatility to be used in community as well as in hospitals
• As the mechanism of action of ArtemiCTM is focused on the anti-inflammatory effect and prevention of cytokine storm, a wide spectrum of potential indications will be considered for future development

NEWS score determines the degree of illness of a patient and prompts critical care intervention. This was defined as a main tool for the estimation of COVID-19 patients clinical health status and improvement.

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The comparison between the study and placebo groups before and after treatment is presented in

Table 1.

	Study visit		Study group			NEWS Score		P
			ArtemiC™	1.5152
	Before treatment							0.54
		Placebo			1.8824
			ArtemiC™	.5152
	Day 15							0.04
		Placebo			2.2353

In line with the interim results released on the 20th August 2020, the Trial met all the FDA requirements for a COVID-19 study including population diversity (age, medical history, and genetic diversity) and demonstrated a full safety profile with no drug related adverse events. This resulted due to ArtemiCTM and the Trial being focused on the immunomodulation specific for the prevention of cytokines storm, as opposed to other immunomodulators.

These results also follow safety and toxicity testing completed on mice (refer ASX release 27 July 2020) and in line with FDA requirements for product registration requiring two types of rodents in pre-clinical trials, MGC Pharma completed an in vivo safety and toxicity pre-clinical study, including histology testing, on 24 rats. This included 4 groups with three 3 study drug dosages being 48ug, 96ug and 196ug per kg rat and a control group. The rats were observed and tested for clinical changes over seven days. This study included pathological examination of the organs: liver, heart, brain, spleen, spinal cord, sciatic nerve, kidney (L+R), lungs and tongue.

The results concluded there were no pathological changes in all tested animal samples.

Next steps

Following the successful Phase II results, further development for ArtemiCTM will include immediate evaluation of a Phase III clinical study on COVID-19 and flu patients, and production in MGC EU GMP facilities as IMP under a new brand name. In addition, different indications related to inflammation and cytokine storm, will be considered as future development goals and include a wide range of diseases related to cytokine storm such as autoimmune diseases, inflammatory GI diseases, flu and chemotherapy patients.

The Company is in a strong position to respond to a significant potential increase in the demand for ArtemiCTM in the immediate future as a supplement, and in the future as part of a Phase III study where the Company would look to develop ArtemiCTM as a pharmaceutical product and future development as an Investigational Medicinal Product (IMP).

Regulatory approvals to commence the Phase III Clinical Trial will be progressed with Anvisa (Brazilian medical Authority), EU Novel Food authority and submissions are expected to be made in first quarter of 2021. The Company plans to develop and commence a Phase III Clinical Trial in the first half of 2021. The Phase III Clinical trial is anticipated to be an international multicentre study with up to 250 patients and expand its research to encompass a wide range of inflammatory indications for the use of ArtemiCTM as a treatment. These indications are related to cytokines storm as autoimmune diseases (rheumatoid arthritis, lupus), flu, chemotherapy patients and IBD could benefit from the mechanism of action ArtemiCTM, demonstrated in preclinical and clinical trials.

Upon completion of a successful Phase III Clinical Trial the Company will seek registration of ArtemiCTM and commence production and sale as a supplement, through its existing production facilities and distribution networks.

Successful results of Phase III will lead for a pre-IND meeting with FDA in order to initiate the registration process for ArtemiCTM as an IMP.

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The ArtemiCTM clinical study on COVID-19 patients is managed under GCP requirements and local Helsinki Committee approvals in 3 hospitals in Israel and 1 in India. The independent management of the study was performed by Dr Nadya Lisovoder, CEO of Galilee Clinical Bio Research, an external Clinical Research Organization (CRO), under all required regulatory conditions answering FDA requirements. Galilee-CBR is an independent Clinical Research Organisation located in Israel provides a full spectrum of clinical development phases I to IV in pharma and medical devices. Galilee- CBR is working with an Israeli Government for the bio medical research promotion in the hospital in Northern Israel. Certified Electronic Data Capture system (provided by Flask Data company, specializes in EDC systems for FDA and EMA clinical trials) was used for the data collection and 100% of the study data was monitored in order to ensure the data quality. Statistical analysis of the results was performed by an external and independent biostatistician, Dr. Nira Morag, a senior lecture in Tel Aviv University, Department of Biostatistics. Nira has more than 30 years of experience in biostatistics in pharma industry.

Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: "The results we have seen from ArtemiCTM to date provide a transformational opportunity for the Company. The safety and efficacy demonstrated on COVID-19patients has now opened the opportunity for a whole range of other indications related to cytokine storm. The Company will now look to progress the immediate opportunities for ArtemiCTM while continuing to pursue further clinical developments."

--Ends--

Authorised for release by the Board, for further information please contact:

PR/IR Advisors - Media & Capital Partners	MGC Pharmaceuticals Ltd
Melissa Hamilton (PR) [phone]	Roby Zomer
Rod Hinchcliffe (IR) [phone]	CEO & Managing Director
[e-mail]	[phone]
[e-mail]	[e-mail]

About MGC Pharma

MGC Pharmaceuticals Ltd (ASX: MXC) is a European based bio-pharma company developing and supplying affordable standardised phytocannabinoid derived medicines to patients globally. The Company's founders were key figures in the global medical cannabis industry and the core business strategy is to develop and supply high quality phytocannabinoid derived medicines for the growing demand in the medical markets in Europe, North America and Australasia. MGC Pharma has a robust product offering targeting two widespread medical conditions - epilepsy and dementia - and has further products in the development pipeline.

Employing its 'Nature to Medicine' strategy, MGC Pharma has partnered with renowned institutions and academia to optimise cultivation and the development of targeted phytocannabinoid derived medicines products prior to production in the Company's EU- GMP Certified manufacturing facility.

MGC Pharma has a number of research collaborations with world renowned academic institutions, and including recent research highlighting the positive impact of using specific phytocannabinoid formulations developed by MGC Pharma in the treatment of glioblastoma, the most aggressive and so far therapeutically resistant primary brain tumour.

MGC Pharma has a growing patient base in Australia, the UK, Brazil and Ireland and has a global distribution footprint via an extensive network of commercial partners meaning that it is poised to supply the global market.

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