MXC.L Regulatory News (MXC)

MGC Pharmaceuticals Ltd.

Completion of CimetrA™ bioanalytics Pre-clinical Trial

10 January 2023

ASX, LSE: MXC

Key Highlights:

· MGC Pharma has completed the full pre-clinical rodents study panel for CimetrATM.

· The latest study, which was carried out at the Smart Assays laboratory in Israel, included the development of bioanalytical methods and validations for further pharmacokinetic analysis for CimetrATM.

· A study on chronic toxicity in rodents was also completed by Science in Action, in Israel, monitoring the potential development of adverse effects from using CimetrATM.

· Histopathology demonstrated the full safety profile for CimetrATM across all study dosage groups.

· The study results are an important step ahead of the submission to the US Food and Drug Administration (FDA) for Investigational New Drug (IND) approval.

· No anomalies were observed in the biopsies, nor were any clinical or behavioural adverse events recorded.

· CimetrATM is MGC Pharma's proprietary Investigational Medicinal Product which in previous clinical trials has demonstrated anti-inflammatory and immunomodulating properties, and is MGC's most clinically advanced product.

MGC Pharmaceuticals Ltd ('MGC Pharma' or 'the Company') a European based pharmaceutical company specialising in the production and development of plant inspired medicines, has completed the pre-clinical rodent studies on CimetrATM, which are a key step in the clinical pathway prior to the planned FDA Investigational New Drug submission. Research using rodent and mammalian models are used to delineate the pharmacokinetic profile and general safety of a drug, as well as to identify toxicity patterns over a given period for the treatment before it advances to the next stage of trials, as required by US Food and Drug Administration (FDA) criteria.

The Study was undertaken to determine toxicological effects of CimetrATM over a 14-day period in rats, and was undertaken by the Smart Assays and Science in Action Laboratories in Israel, and comprised four study groups, three separate dosage groups, and one control group, with the treatment administered over a period of fourteen days, followed by a seven day review period. Blood samples for the pharmacokinetic analysis were taken on a daily basis, and histopathology tests were conducted on all organs per FDA guidelines. No anomalies were observed in the biopsies taken, nor were any clinical or behavioural adverse events recorded.

This Study is crucially important in the regulatory approval process for Investigational New Drugs (IND) approval by the FDA, and forms a key part of the metrics for the FDA's Center for Drug Evaluation and Research (CDER), the commercial and consumer watchdog, and gatekeeper to the US pharmaceutical market. There is a strict process for FDA approval: discovery, preclinical development, and clinical trial, where the boundary between preclinical development and clinical trial is sharply defined by the IND approval. Final FDA approvals will ensure that CimetrATM meets the criteria for further clinical study and development in the US, and ultimately commercial sale, therefore opening up the largest healthcare market globally to MGC Pharma.

Roby Zomer, co-founder, Managing Director and CEO of MGC Pharmaceuticals, commented: "The successful completion of this study and the excellent results attained is an important milestone moment for the Company, as we continue to progress CimetrATM along the mandated clinical pathway. The results of this study are a critical step in advancing MGC's submission to the FDA, and for the final approval of CimetrATM as an Investigational New Drug in the US."

A summary of results from the recently completed study can be found in Annexure A below.

About CimetrATM

CimetrATM is a nanoparticle micellar formulation based on the pharmaceutical synergetic composition consisting of Curcumin and Boswellia. In pre-clinical and clinical trials CimetrATM has demonstrated anti-inflammatory and immunomodulating effects, and can be designed for multiple therapeutic applications utilising Graft Polymer IP Ltd's proprietary GraftBioTM Self-nano-emulsifying Drug Delivery System.

Preclinical and clinical results to date have demonstrated CimetrATM's mechanism of action as an anti-inflammatory and immunomodulatory agent which is effective in the prevention of severe inflammation by its control of increased Cytokine production resulting from an infection of the different variants of SARS-CoV-2 (the virus responsible for COVID-19); and which is the forerunner of a Cytokine Storm, which is believed to be the main reason for mortality in severe COVID-19 patients.

--Ends--

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About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based pharmaceutical company, focused on developing and supplying accessible and ethically produced plant inspired medicines, combining in-house research with innovative technologies, with the goal of finding or producing treatments to for unmet medical conditions.

The Company's founders and executives are key figures in the global pharmaceuticals industry and the core business strategy is to develop and supply high quality plant inspired medicines for the growing demand in the medical markets in Europe, North America and Australasia.

MGC Pharma has a robust development pipeline targeting two widespread medical conditions and has further products under development. 

MGC Pharma has partnered with renowned institutions and academia to optimise the development of targeted plant inspired medicines, to be produced in the Company's EU-GMP Certified manufacturing facilities. 

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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Annexure A

Study Results

Histopathological examination

Severity of changes were scored by a 5-point scale as follows (Schafer et al., Toxicol Pathol 2018, 46:256-265):

Grade 0 - Normal (within range of normal histological variations)

Grade 1 - Minimal 

Grade 2 - Mild

Grade 3 - Moderate

Grade 4 - Severe

Findings

· No pathological nor cytotoxic changes at all were found in the organs and tissue biopsies of the test subjects, i.e. All tissues of all animals were unaffected.

· The semi-quantitative results are presented below in Table A and B.

· All tissues of all animals were normal. It was concluded that the test article at the dosage administered did not induce toxicological changes.

1. Refer annexure B "Treatment method, route, frequency, dose levels" section for treatment dosage information

ANNEXURE B

Study Protocols