Late last year, the company announced it would be the recipient of a 3.1 million Euro (~A$5 million) cash grant to set up a fully functional GMP certified facility in Malta to produce a COVID-19 anti-inflammatory product ArtemiC™ in liquid dose form.
The grant from Malta Enterprise will enable the company to renovate and extend its existing Clinical Research Organisation (CRO) facility in Malta.
This will create a European manufacturing hub for ArtemiC™ with the ability to scale production to meet expected growing demand following positive clinical trial results.
The European Union GMP-compliant facility will be able to produce 10,000 units of liquid dose medicines per day.
European manufacturing hub
The company has received strong support from the Maltese government through Malta Enterprise to establish the world-class GMP facility to respond to the growing pharma and cannabis industries on the island.
Construction of the extension to the MXC Malta facility has commenced and is expected to be completed in the second quarter of 2021.
Upon completion of the facility, MGC Pharma will be in a strong position to streamline global distribution via Malta’s convenient shipping access to the entire globe.
Initial target markets for the distribution of ArtemiC™ will be Israel, Russia, the CIS countries and countries in the Balkan region as determined by a distribution agreement signed with KS Kim International, a wholly-owned subsidiary of SK-Pharma group.
ArtemiC™ strong clinical trial results
In December, the company’s Phase II double-blind, placebo-controlled clinical trial for ArtemiC™ on those diagnosed with COVID-19 met all the Phase II primary and secondary endpoints and was demonstrated to improve the clinical recovery of the patients.
This 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 with 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.
MGC Pharma 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.
Phase III clinical study planned in H1
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.
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.
Supply agreements and production
On trial completion and the release of positive results, the production of ArtemiC™ will move to MGC Pharma’s GMP-certified production facility in Slovenia.
It expects to rapidly advance discussions on a commercial scale for ArtemiC™ supply agreements on publication of the positive data.
Additionally, MGC Pharma is exploring the wider uses of ArtemiC™ to encompass other conditions that cause cytokines storm.
UN reclassification implications
Notably, MGC Pharmaceuticals is well-positioned to benefit from the UN’s decision late last year to remove cannabis and its derivatives from schedule IV following recommendations from the World Health Organisation (WHO).
Cannabis and its derivatives will now be contained under Schedule I of the 1961 UN Single
This removal, alongside other recent legislative changes, further demonstrates the rapidly changing political perspectives on cannabis and the use of cannabis for medicinal purposes which will make operating in the sector less challenging, more efficient and more profitable.
The company believes this effectively validates the global medicinal phytocannabinoid market where MGC Pharma has been established and operating for a number of years.
This gives the company first-mover advantage and the company's flagship phytomedicines will have far fewer obstacles to overcome as they work towards market authorisation, registration and patient access.