MXC.L Regulatory News (MXC)

MGC Pharmaceuticals Ltd

Roby Zomer

CEO & Managing Director

+61 8 6382 3390

info@mgcpharma.com.au

MGC Pharmaceuticals Ltd

David Lim

Company Secretary

+61 8 6382 3390

info@mgcpharma.com.au  

UK Financial and Corporate Advisor

Hannam & Partners

Rupert Fane / Nilesh Patel

+44 7810 056 104

rf@hannam.partners / nilesh@hannam.partners

UK Broker

Turner Pope

Andy Thacker

+44 203 657 0050

info@turnerpope.com

UK PR Advisors

Tavistock

Charles Vivian / Tim Pearson

+44 207 920 3150

mgcpharma@tavistock.co.uk

Sponsor

Swiss Pharmacan AG

Name and any unique identifier of the trial:

Research study to evaluate the clinical effectiveness of the nutritional supplement VITAMIC BIOSEN® on individuals with symptoms consistent with persistent Covid who have been vaccinated against the SARS-CoV2.

(VITAMIC BIOSEN® is white label version of MGC Pharma's ArtemiCTM product)

Primary endpoint(s):

Individual self-completed surveys will be conducted by all study participants via the eCRD (Electronic Data Collection Booklet ANNEX III). These will be carried out on the day of inclusion in the study, before starting treatment, and in the sixth week at the end of treatment.

Two scales will be completed:

• Post-COVID Functional Scale (PCFS) (ANNEX IV) and assessing post-COVID symptomatology.

• EuroQol5D Quality of Life Questionnaire (ANNEX V).

After completing the surveys on the day of inclusion, they will start taking VITAMIC BIOSEN®, at a dose of 10 drops twice a day orally for 6 weeks in addition to any treatments the patient may be taking under normal clinical practice.

All data will be collected in the eCRD created for the project, which will be stored encrypted and after the use of the corresponding pseudo-anonymization procedure for the protection of personal data

Secondary endpoints:

For the secondary objective, Cohort B:

A subgroup of 20 participants (making up Cohort B) will have blood tests performed in routine clinical practice. A sample of venous peripheral blood (3-4 ml) will be taken from the arm, fasting and first thing in the morning.

After 6 weeks, the indicated test will be repeated, and results will be compared between the baseline and final situation.

The study will use the multi-analytical molecular laboratory test ENCHEPAX™, from the company PERSONA BIOMED SPAIN SL (ANNEX VI).

All data will be collected in the eCRD created for the project, which will be stored encrypted and after the use of the corresponding pseudo-anonymization procedure for the protection of personal data.

Symptomatology according to the 10-point Likert scale on and six weeks after treatment initiation. The following symptoms were measured::

1. Dyspnea

2. Cough

3. Asthenia

4. Anosmia

5. Ageusia

6. Headache

7. Mental confusion

Description of Control Group:

A control group was not used in this study.

Blinding status:

N/A

Product status:

VITAMIC BIOSEN® is an approved food supplement with extensive experience of use and an excellent safety profile. As the basic type of treatment in these patients with persistent COVID remains unchanged, this study is considered to have a very low level of intervention.

(Vitamic Biosen® is a white label version of MGC Pharma's ArtemiCTM product).

Treatment method, route, frequency, dose levels:

Following the initial assessment, a decision was made for inclusion of the candidate, given all inclusion criteria work and no exclusion criteria harm. Following this, two bottles of VITAMIC BIOSEN® was provided to the patient and a demonstration was done to show how the portioning by drops should be done.

Cohort A:

Study entry data were collected through interviews conducted by healthcare personnel.

In this interview, data were collected on the state of health (symptoms present, using a 10 point Likert scale), any doubts they might have about the treatment or the study were resolved, and the functional impairment and quality of life scales were performed.

After six weeks (at the end of the study), this process was repeated by means of an interview conducted by health personnel, in such a way that the symptoms present were recorded as well as the evaluation of the Functional Affectation Scale and the Quality of Life Scale.

Cohort B:

Input data were collected for the 20 participants by the Principal Investigator, through personal interview where in addition to collecting the clinical data necessary to perform the biomarker test, questions or doubts related to the study or treatment were addressed.

Similarly, the functional assessment and quality of life scales were carried out, both at the beginning and at the end of the 6-week follow-up of the study.

Day one (1) was the day of first intake.

On the day of inclusion and first assessment, the investigator carefully explained the aim and the design of the study and delivered a relevant information sheet. Following this, the patient signed the consent form.

Case Report Form (CRF): A database tool was designed specifically for this study. The data was registered at the moment of the interview, either on paper, or electronically. Concomitant medication was documented. Investigators were encouraged to just observe and document what they saw and heard in a highly objective way.

Key tools that were used were the Post Covid Functional Scale (PCFS), EuroQol5D Quality of Life Questionnaire and 10-point Likert Scales regarding Dyspnea, Cough, Asthenia, Anosmia, Ageusia, Headache and Mental Confusion.

Data was collected by healthcare professionals, either nurses or medics.

Number of trial subjects:

Total of 60 patients in Spain who suffer from post-acute COVID Syndrome (Long COVID Syndrome).

· 87.5% women with an average age of 47.76 years

· 12.5% male with an average age of 43.16 years

100% vaccinated at first interview.

The 60 patients included in the study and were assigned to the two cohorts as follows:

- Cohort A (does not include biomarker analysis): made up of 40 patients who met all the criteria and who, for various reasons (place of residence, self-will, reduced mobility,...), did not wish to undergo blood collection twice (as indicated in the protocol), to determine biomarker values.

- Cohort B (includes biomarker analysis), formed by 20 patients, who communicated their willingness and disposition to undergo both extractions in the clinics authorized for this purpose and on the dates indicated in order to comply with the deadlines established in the protocol. Likewise, in order to create a homogeneous cohort, the persons with the most similar clinical, anthropometric and hygienic and dietary profile were selected.

The individuals were selected from all the Spanish territory and the follow-up was carried out by means of personal interviews with the research team of the study.

Likewise, an e-mail address was set up on the web site created for the study to attend to any doubts or questions that the participants might have during the 6 weeks of follow-up of the study. In this regard, 19 queries were registered through this system, which were answered by the principal investigator.

For the extraction of the blood samples necessary for the biomarker test, 4 clinics with clinical analysis services were selected, located in the cities of:

Madrid, Barcelona, Castellon and Valencia.

Each patient underwent two extractions in the same center 6 weeks apart and after treatment with VITAMIC BIOSEN.

The samples obtained were processed according to the procedures defined by the manufacturer of the ENCHEPAX™ test, and were duly coded to ensure compliance with the data protection law.

The analytical procedure was performed at the facilities of PERSONA BIOMED SPAIN, as the manufacturer of the ENCHEPAX test, and all samples were processed by them on the same analytical plate to avoid any possible distortion factor.

Subject selection criteria:

Screening of patients was based on subjects attending consultations in medical practices and on associations caring for patients suffering from Long-COVID. Subjects who met the overall inclusion criteria were invited to participate in the study.

Inclusion Criteria

· Persisting post-acute COVID syndrome (PACS) symptomatology of more than one month, with Post Covid Functional Score (PCFS) between one and four.

· Individuals between 18 and 80 years of age presenting some of the following symptoms: cough, dyspnoea, asthenia, anosmia, ageusia, headache and mental confusion.

· The patient must have received at least one dose of any vaccine offered by the Spanish health system.

· The patient must be able to complete the follow-up assessments.

· The patient agrees to take the VITAMIC BIOSEN® food supplement, assigned during the 6 weeks.

Exclusion Criteria

· Known hypersensitivity to VITAMIC BIOSEN®

· Active malignancy

· Current or recent chemotherapy treatment (

· Medical history of Human Immunodeficiency Virus (HIV) infection, or any serious

· immunocompromised state

· Use of montelukast or zafirlukast ≤ 30 days prior inclusion

· Having participated in another clinical trial in the previous month

· Women that are pregnant or breastfeeding

Trial locations:

Madrid, Barcelona, Castellon and Valencia.

Report Author:

Dr. Francisco Mera Cordero

Statistical Analysis

The statistical analysis will be descriptive. The change in the three scales will be described, comparing the scales on the day of inclusion with those at week six.

A description will also be given for each of the seven 10-point Likert scales, comparing the item values on the day of inclusion with those at week six.

Convenience sampling, which is a non-probability, non-random sampling technique, will be carried out in which the persons included in the research project are purposively determined based on the inclusion and exclusion criteria mentioned above.

Subsequently, the type of variables collected in the study will be determined as a preliminary step to choose the most appropriate and valid methods of analysis of the dependent variables, independent variables, factors related to the patient, the disease, and the treatment, which will be studied to determine whether there is an association with the dependent variable.

Measures of central tendency (mean, median and mode) and dispersion will be used for quantitative variables, and, in the case of qualitative variables, data will be collected in frequency tables, expressed in terms of proportion, and noted in brackets. To carry out association studies, a univariate analysis will be carried out for each of the independent variables mentioned above.

To compare groups of categorical variables, the chi-square (X2) and Fisher's exact probability tests will be used as hypothesis tests; the student's t-test or the Mann-Whitney U-test will be applied for quantitative data. To compare continuous quantitative variables in related samples, the t-test shall be used if the distribution is normal or the Wilcoxon signed-rank test if the distribution is non-normal. The significance level will be considered at < 0.05 (two-tailed).

Hierarchical cluster analysis will be used to group patients according to their pattern of similarity by plasma levels of the biomarkers studied. The analysis will use mathematical algorithms to quantify the similarities between subjects within each subgroup and define subgroups where similarities are strongest between patients in the same subgroup and weakest in relation to patients in other subgroups. Hierarchical cluster analysis will also identify patterns of association between molecular and genetic biomarkers, which will help to interpret mechanistic relationships in the processes in which they are involved.

Trial standard:

The study will be governed by the basic ethical principles contained in the Declaration of Helsinki (WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI. Ethical Principles For Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 and note of clarification on paragraph 29 added by the WMA General Assembly, Washington 2002) and in the Spanish regulations in force for the performance of observational studies (SAS/3470/2009, of 16 December) and will be subject to prior approval by the Ethics Committee of any of the hospitals involved.