ArtemiC Phase II Clinical Trial Results

MGC Pharmaceuticals, a partner of Swiss PharmaCan, is currently conducting a clinical trial testing the effectiveness and safety of a MyCell Technology-based formulation with respect to COVID-19. Read all about the trial in this press release.

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Key Highlights:

 

  • Full results of MGC Pharma’s phase II double blind clinical trial show ArtemiC has successfully met the primary and secondary study endpoints

  • ArtemiC 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

  • ArtemiC 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

  • ArtemiC 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 ArtemiC

  • These results now open potential market opportunities for ArtemiC 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 ArtemiC 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 biopharma company specialising in the production and development of phytocannabinoid-derived medicines, is pleased to announce the full results of its Phase II double-blind, placebo-controlled clinical trial for anti inflammatory treatment ArtemiC, 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-19 patients. The (“Trial”).

Key Trial Results

The Company has completed its Trial on ArtemiC 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.

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, ArtemiC 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 ArtemiC 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.

The comparison between the study and placebo groups before and after treatment is presented in
Table 1.

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 ArtemiC 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 sample

Next steps

 

Following the successful Phase II results, further development for ArtemiC 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 ArtemiC 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 ArtemiC 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 ArtemiC 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 ArtemiC, demonstrated in preclinical and clinical trials.

 

Upon completion of a successful Phase III Clinical Trial the Company will seek registration of ArtemiC™ 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 ArtemiC as an IMP.

 

The ArtemiC 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. GalileeCBR 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 ArtemiC™ to date provide a transformational opportunity for the Company. The safety and efficacy demonstrated on COVID-19 patients 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 ArtemiC™ while continuing to pursue further clinical developments.”
 

Further information and the annexure can be found inside the PDF.