MGC Pharma recently announced that it was going ahead with three clinical studies on three separate drugs in 2021.
The clinical trials will be conducted on the company’s candidate drugs CimetrA, CannEpil, and CogniCann, to be done across Israel, Brazil, and Australia.
Stockhead caught up with MGC Pharma CEO, Robert Zomer, and asked him about the progress of each of these trials.
Born in Israel, Zomer has an interesting background, having studied sound engineering and was previously a music producer and DJ.
While working in a music venue, he started a company with a friend, dealing with biofuel biodiesel.
That started his entrepreneurial journey, which eventually led to pharmaceuticals in 2015, and eventually to the CEO role of MGC Pharma.
“I will say that production of music and establishing a company as an entrpreneur have a lot of similarities,” Zomer explained.
“Producing a good album or good music festival, and producing a good company as an enterpreneur contain a lot of similarities. So it was very easy for me to understand the business world.”
CimetrA Phase III clinical study
The Phase III clinical trial of CimetrA was designed to evaluate the efficacy and safety of the drug for hospitalised patients diagnosed with COVID-19.
Zomer knows the effects of COVID-19 all too well, as he and his family – along with 20 per cent of MGC Pharma staff – fell victim to the virus. All have since recovered.
He explained that the CimetrA is now entering its Phase 3 trials in Israel, with a submission in Brazil as the Covid-19 situation escalated in that country.
CimetrA completed its Phase 2 trial last year, with a 100 per cent success rate in achieving both the primary and secondary end point – the reduction and prevention of the symptoms.
The company has also completed the patent application on CimetrA, which will now protect the drug from future competition.
Asked if the CimetrA should be taken in conjunction with the currently available vaccine, Zomer said CimetrA is not a substitute for the vaccine.
“We’re not treating the virus itself, we’re treating the immune reaction to the virus,” he said.
“So CimetrA is not a substitute (for vaccine) and it will not prevent Covid-19. The drug is not directed at a certain variant or a mutation of Covid, so it works for any variants. Rather, it targets the causes cytokine storm,” Zomer said.
During a cytokine storm, various inflammatory cytokines are produced at a much higher rate than normal, which leads to organ damage. It’s the main reason for mortality in Covid-19 patients.
MGC has also completed pre-clinical studies that demonstrated the drug’s effectiveness on any cause of the cytokine storm, which means it is agnostic to any mutants of the virus, including the Indian and the Brazilian variants.
This meant that the use of CimetrA would have wider applications, including other viral infection diseases.
“The company also intends to explore other elements of other viruses and infectious diseases, that cause cytokine storm including simple influenza or pneumonia. Even Car T and chemotherapy treatments, we’ll able to treat all of that.”
Interim results from the trials are expected to be released in August, and final results in Q4 of 2021.
The CannEpil Phase IIb clinical study
The CannEpil, which is short for Cannabis Epilepsy, will be studied in a Phase IIb clinical trial at the the Schindler Hospital in Israel.
The study will focus on the safety and efficacy of CannEpil as an add-on treatment in children and adolescents with refractory epilepsy.
The trial will commence in July, with more than 100 patients to be recruited starting in June after obtaining approval from the Israeli Ministry of Health.
The drug was designed through studies that have been conducted globally, and through the history of treatment by one of the leading doctors in Israel.
Observational studies were also conducted in Australia by prescribing the drugs to different patients over the last three years.
The drug is meant to reduce seizures targeting the severe cases of epilepsies for patients who experience more than 10 seizeures a day.
According to Zomer, this represents 25 per cent of all epilepsy patients.
“So we’re talking about a very large group of patients. If we want to compare it to Dilex, which is an FDA approved drug, they only target 2% of the epilepsy patients. CannEpil is targeting a much larger group,” explained Zomer.
MGC has also initiated a study of CannEpil in Australia, to demonstrate the safety of the drugs when used by drivers.
The Driving Safety study of CannEpil in Australia was conducted following the reopening of universities after the Covid-19 lockdowns.
This trial will involve 31 healthy volunteers to be recruited by October, and aims to provide supportive safety data to the Australian regulatory authorities.
CogniCann Phase II clinical trial
The Phase II clinical trial of CogniCann will be conducted at the University of Notre Dame in Perth.
This study will evaluate the potential behavioural benefits of CogniCann on patients with dementia and Alzheimer’s disease.
The study was delayed by Covid-19 restrictions, but recruitment has now recommenced, with 21 patients enrolled in the trial over the last three months, out of a target of 50 patients.
“We are not bringing back people’s memory, but what we’re doing is improving the quality of living by reducing anxiety, improving diet, and side effects from the symptoms created by dementia and Alzheimer’s,” Zomer said.
“We’re also trying to improve their cognitive response by being less anxious about not remembering things, and being more relaxed which allow you to actually remember more.”
Asked what the company’s core mission was, Zomer said:
“It’s quite simple. MGC Pharma’s core purpose is to produce and provide phytomedicine. Phytomedicine are organic based medicine, with primary phyto canabinoids, because our primary active substance will be cannabinoids.”
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