MGC Pharmaceuticals Ltd’s (ASX:MXC) (OTCMKTS:MGCLF) (FRA:H5O) Phase II double-blind, placebo-controlled clinical trial for anti-inflammatory treatment ArtemiC, based on Swiss PharmaCan AG MyCell Enhanced™ delivery system technology, on those diagnosed with COVID-19, has met all the Phase II primary and secondary endpoints and demonstrated to improve the clinical recovery of the patients.
The European-based biopharma company specialising in the production and development of phytocannabinoid-derived medicines is now 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.
It plans to develop ArtemiC as a pharmaceutical product and future development as an Investigational Medicinal Product (IMP).
MGC shares have risen as high as 32% to A$0.042 cents in early trading on string volume of more than 136 million, approaching the 12-month high of A$0.043.
Progress immediate opportunities
MGC Pharma co-founder and managing director Roby Zomer said: “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.
Key trial results
The Phase II trial involved 50 infected patients across three independent hospital sites in Israel and India, with 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.><0.04) than in the treatment group -0.5
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; and
➢ 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.
Phase III clinical study in first half 2021
Further development for ArtemiC will include immediate evaluation of a Phase III clinical study on COVID-19 and flu patients, and production in the company’s EU GMP facilities, as IMP under a new brand name.
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.
Regulatory approvals to commence the Phase III Clinical Trial will be progressed with the Brazilian medical authority (Anvisa), the EU Novel Food Authority and submissions are expected to be made in the 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 Food and Drug Administration (FDA, to initiate the registration process for ArtemiC as an IMP.