The Australian Therapeutic Goods Administration (TGA) has granted key approvals to the ASX-listed biotech firm, MGC Pharmaceuticals (ASX: MXC), to begin Phase IIB clinical trials of a new "CogniCann" medical cannabis product for patients suffering from dementia and Alzheimer's.
The trial is set to run for a total of 16 weeks, and will be conducted on 50 patients aged 65 and older to asses the efficacy of CogniCann in treating dementia patient's symptoms. According to MGC Pharmaceuticals, the drug was created with a THC:CBD ratio "specifically formulated for the treatment of key dementia symptoms and improving specific cognitive functions".
Currently, the study is on track to begin in the first half of this year, and will be carried out at the University of Notre Dame, WA. A researcher involved with the study, Professor Jim Codde, characterised the drug trials as a critical health initiative.
"Health research, especially into issues affecting those most in need within our community, is of the highest priority to Notre Dame," Codde said.
"Research initiatives into dementia is also a national priority so we are very excited to work with MGC and the aged care sector to trial this novel approach to improve the quality of life for the almost 350,000 Australians suffering this disease that currently has no cure."
The trial is designed to be a randomised, double-blind, and placebo-controlled, and will evaluate the drug's effect on the patient's quality of life, level of discomfort or pain, and any behavioural changes that may occur.
That's Grow Biz
The company recently reached another landmark achievement, after its' manufacturing facility—located in Ljubljana, Slovenia—received one of the European Union's first approvals to extract and develop Phytocannabinoid active pharmaceutical ingredients (API). This has given MGC a considerable competitive advantage as it pursues full vertical integration in the increasingly crowded biopharma market.
MGC Pharmaceuticals was also the first Australian cannabis company to be granted qualification for all of its' Phytomedicines from the European Medicines Agency, allowing it to apply for drug evaluation and registration of CogniCann, CannEpil, and any other medicinal cannabis products currently being developed.
CannEpil is another cannabis-based medicine developed by MGC that is intended to aid the sufferers of epilepsy regulate their symptoms. A growing amount of medical practitioners have already been granted approval to prescribe the drug to Australian customers.
According to the chairman of MGC Pharmaceuticals, Brett Mitchell, the progress of its' pharma business is "evidence of the tireless work behind the scenes from the entire MXC team and we expect 2019 to deliver significantly more growth and development".
"The achievement of these milestones demonstrates material progress on MXC's pathway to commercialisation and is testament to the Executive Management's commitment to building a strong company under its seed-to-pharma strategy," Mitchell said.
MGC also recently signed off on the sale of the company's cannabis-based cosmetics division, MGC Derma, to the Canadian cannabis investment group, CannaGlobal. The managing director of MGC, Roby Zomer, was bullish about the deal's completion, saying that it will allow the company to focus on developing pharmaceutical products and making its' "seed-to-pharma" business model a reality.
"We are pleased to report that MGC Derma has now been fully divested and is under the CannaGlobal investment portfolio," Zomer said.
"We are now fully focussed on growing MXC as a pure bio-pharma company with a direct pathway to commercialisation, as demonstrated following the recent arrival of our first CannEpil product in Australia."
As part of the sale, MGC will receive a 10% stake in CannaGlobal—while continuing to supply raw cosmetic material to the company for a least five years—allowing it to retain exposure to the increasingly lucrative cannabis-based cosmetics market.
Once the CogniCann trial is complete, MGC Pharmaceuticals will own the rights to all research findings, and any Intellectual Property (IP) that is developed as a result. The company's eventual goal is to obtain a "worldwide non-exclusive, royalty-free licence" to make use of the trial's IP for commercial and research purposes.
"This represents a milestone for MGC, which is on the road to becoming a biopharmaceutical company with a library of medicinal cannabis formulations that have been compounded into final medications for the treatment of a wide range of indications."
– MGC Pharmaceuticals
News of the trial's approval caused the price of MGC shares to jump to 4.4 cents, although as of January 31st the stock has dipped to 4.0. However, the study is due to begin before July, so it seems likely that future updates will lead to further boosts in share value. The same thing happened previously in January 2018, when the manufacturing kick-off for CannEpil caused the stock to spike in value by 10%.
MGC managing director Roby Zomer was enthusiastic about the trial's approval, saying that it would provide the next stepping stone in its' growth strategy.
"We are pleased to have received ethics approval for our Phase II clinical trial assessing the effects of our medicinal cannabis medicine, CogniCannTM on patients with mild dementia and are excited to start working with the superior team of researchers at the University of Notre Dame."
"We are building strong relationships in the medical research industry and see this as taking the next step in our strategic growth and development of our seed-to-pharma capabilities," he said.
The drug's development is good news for the estimated 425,000 Australians currently living with dementia—which is the second leading cause of death in the country—and other forms of age-based cognitive decline.
Market research has confirmed that this number is likely to swell to 1.1 million by 2056. The report, entitled The Economic Cost of Dementia in Australia 2016-2056, also found that if new treatments are not developed then the eventual cost to the economy will exceed $36 billion within 40 years.
If MGC's trial is successful, then it may pave the way for medical cannabis to become a cornerstone of future dementia treatment. What remains to be seen is if the company's "seed-to-pharma" approach to the industry will pay off.