Biopharma developer MGC Pharmaceuticals (ASX: MXC) plans to apply the potential benefits of cannabis to mitigate the impact of dementia.
Earlier this morning, the company announced it has been granted “full ethics approval” to conduct a phase 2 clinical trial into the effects of CogniCann, MGC’s certified, pharmaceutical-grade medicinal cannabis product developed for patients with mild dementia and Alzheimer’s disease.
MGC currently makes a range of GMP-certified pharmaceuticals within its EU production and manufacturing facility, as part of its “seed-to-pharma” business model. The company says its CogniCann product harnesses a THC:CBD ratio “specifically formulated for the treatment of key dementia symptoms and improving specific cognitive functions”.
According to MGC, CogniCann will be tested on a total of 50 participants aged 65 years and older as part of a series of pre and post-treatment surveys that will be used to assess the effects and responses from both patients, medical staff and family members, regarding the efficacy of the treatment.
“We are pleased to have received ethics approval for our Phase II clinical trial assessing the effects of our medicinal cannabis medicine, CogniCann on patients with mild dementia and are excited to start working with the superior team of researchers at the University of Notre Dame,” said Roby Zomer, co-founder and managing director of MGC Pharmaceuticals.
“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,” said Mr Zomer.
Professor Jim Codde from the University of Notre Dame said that “health research, especially into issues affecting those most in need within our community, is of the highest priority to Notre Dame. Research initiatives into dementia is also a national priority so we are very excited to work with MXC 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.”
Approving cannabis for treating dementia
To be granted full approval, MGC had to complete a full ethical review, undertaken by the Human Research Ethics Committee (HREC) at the University of Notre Dame in Western Australia (UNDA), in accordance with the National Statement on Ethical Conduct in Human Research.
The forthcoming trial is expected to commence in early 2019 and will last around 16 weeks, to be undertaken by the University’s Institute for Health Research.
The trial remains subject to TGA approval which will ultimately require a randomised, double-blind, crossover, placebo-control design to evaluate the behavioural changes, quality of life, and level of discomfort and pain in Dementia patients living in residential aged care facilities.
Upon completion of the trial, MGC says it will own all IP and results and hopes to acquire a “worldwide non-exclusive, royalty-free licence” to use the project’s intellectual property for non-commercial research purposes including research publications.
“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,” according to MGC Pharmaceuticals.
Pfizer’s bad example?
Today’s move by MGC could prove to be a rather timely one following Pfizer’s shock decision to pull out of all research into treatments for dementia and Alzheimer’s disease earlier this year.
Pfizer is a leading US-based pharmaceutical giant that makes hundreds of different drugs and is a leader in developing drug treatments for various diseases.
In January this year, president of Pfizer Worldwide Research and Development Mikael Dolsten said the decision was “driven by science not cost” and confirmed the company was facing “continual setbacks” in developing viable drugs that treat dementia.
Today, there are more than 425,000 Australians living with dementia with the disease considered as the second-leading cause of death in Australia. Furthermore, dementia has been confirmed to be the leading cause of death among Australian women.
According to market research, Australia could have as many as 1.1 million dementia sufferers by 2056, but with major pharma companies such as Pfizer halting development, the future for “truly transformational therapies” coming from big pharma is somewhat bleak.
MGC’s trial will commence next year and if proven to be successful, it could lead to medical cannabis becoming a staple medicine in fighting dementia in the years to come, similar to how Epidolex became the world’s first cannabis-based drug to treat epilepsy in June this year.