Media Releases

 

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SYMBYX announces start of ground-breaking Parkinson’s light therapy trial in Canada; Pathway to FDA & Health Canada approvals

 

March 31 2022 

• Ethics approval received for Parkinson’s light clinical trial
• First Canadian study to examine efficacy of treatment on Parkinson’s symptoms
• Trial to involve 50 participants, a placebo group, and will run initially over 12-weeks

SYMBYX, an Australian medical laser company developing light therapies to reduce the debilitating symptoms of Parkinson’s and other chronic conditions, today said it will begin a major clinical trial in Canada using its proprietary treatment system.

The trial is approved by Advarra Institutional Review Board (IRB).

Anita Saltmarche, a leading neuroscientist and clinician in Toronto, and Orla Hares, a neuro physiotherapist with a special interest in Parkinson's rehabilitation in Hamilton ON, are the co-principal investigators of the study. They will be assisted by a team of US and Australian scientists. This is the first North American study to examine the effectiveness of light, known as photobiomodulation (PBM) in reducing Parkinson’s debilitating symptoms. Patient recruitment will commence in April 2022.

Parkinson’s is the world’s fastest growing neurodegenerative disorder, ahead of Alzheimer’s. It is currently incurable. It is a progressive neurological condition caused by a lack of dopamine, a neurotransmitter or chemical messenger in a part of the brain (the basal ganglia) produced naturally, affecting our behaviour and physical functioning such as mood, attention, sleep and movement. Symptoms include muscle rigidity, pain, tremor, difficulty walking as well as depression, anxiety, compromised swallowing and a loss of sense of smell.

 

Parkinson’s affects between 12 and 15 million people worldwide. The incidence in Canada is expected to climb above 200,000 diagnosed people before the end of the decade. It is believed many more remain undiagnosed. Treatments account for the third highest direct healthcare cost in Canada annually, behind epilepsy and dementia. Parkinson’s sufferers, as a group, are also amongst the heaviest users of prescription drugs in Canada.

 

“PBM is the use of red and near-infrared light to stimulate healing, relieve pain and reduce inflammation,” Ms Saltmarche said.

 

“We know it is effective in treating various neurological conditions, including concussion, dementia, aphasia post-stroke, and autism. The therapy is non-invasive, safe and effective,” she said.

 

“The SYMBYX treatment system already has regulatory approval in the UK, EU, Australia & NZ. Our trial will involve PBM plus exercise. We anticipate publishing initial results by fall 2022.”

 

Patients previously treated with PBM have returned to playing the piano, report being able to shop, carry groceries and garden more easily. Some have recovered their sense of smell.

Earlier trials conducted in Adelaide (published in BMC Neurology UK, 2021) and Sydney (published in Photobiomodulation, Photomedicineand Laser Surgery, 2022), showed significant reductions in patient symptoms. Patients involved in trials in Adelaide showed improved mobility, cognition, dynamic balance and fine motor skills after 12 weeks. Patients have maintained their benefits for over two years. A more recent trial conducted in Sydney showed PBM to be an effective treatment for a number of clinical signs with some being maintained despite lengthy COVID lockdown restrictions.

SYMBYX has also recently partnered with The Hospital Research Group (supporting people with Parkinson’s in South Australia and the Northern Territory) and Flinders University to run a separate trial in Australia.

This trial will run over 52-weeks, include a control group and be double- blinded, thus reducing the potential for placebo effect. 

“The combined patient numbers from the new Canadian and Australian trials will add significantly to the existing body of evidence supporting PBM therapy for Parkinson’s”, according to SYMBYX CEO Dr Wayne Markman.

“The Canadian results will form the foundation of our FDA and Health Canada approvals,” he said.

“This is critical research into what historically has been an intractable, neurodegenerative condition that typically doesn’t improve. The best results are definitely achieved in conjunction with a healthy diet, regular exercise, a realistic approach to treatment and care from qualified practitioners and supportive family members.”

Background:

PBM works in several ways to reduce Parkinson’s symptoms:

• it targets cell mitochondria (the engine of the cell), where the cell’s energy is produced (known as ATP) driving all human life - fatigue is a common symptom of Parkinson’s;
• ion channels in nerves are modulated downwards resulting in reduced chronic pain associated with muscle spasm and rigidity;
• inflammation is reduced through metabolism of anti-inflammatory bio-markers;
• additional neuro-transmitters, already in short supply in a Parkinson’s patient, are manufactured in the gut – over half our dopamine and 85% of our serotonin is actually metabolised in the colon;
• treatment therefore has a typically positive cognitive effect (reducing ‘brain fog’ while improving sleep, speech, mood and initiative);
• motor improvements include balance, gait and fine motor control such as handwriting.

 

For media enquiries, please contact Michelle Innis

P&L Corporate Communications Sydney, Australia 61 414 999693 michelle.innis@plcorporate.com.au

Co-Principle Investigators, Anita Saltmarche and Orla Hares are available in Canada on 426 579 5773 or 416 770 6005, respectively.

Photos available upon request. 

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SYMBYX announces two new clinical trials for Parkinson’s and a clear pathway seeking FDA approval

 

January 6, 2021

SYMBYX, an Australian medtech developing laser light therapies to reduce the debilitating symptoms of Parkinson’s, has begun preparations for two further clinical trials. One will be conducted in Adelaide and the second in Toronto, Canada.

Working with Olivia Nassaris, Executive Director of The Hospital Research Group Foundation – Parkinson’s (supporting people with Parkinson’s Disease in SA and NT) and Flinders University’s Dr Joyce Ramos; as well as Canadian neuroscientist and clinician Dr Anita Saltmarche, each trial will test the effectiveness of medical-grade light therapy (also known as photobiomodulation), delivered with SYMBYX devices and treatment protocols. Earlier clinical trials, conducted in Adelaide (published in BMC Neurology Journal) and Sydney (published in Photobiomodulation, Photomedicine and Laser Surgery - “PPL”), showed significant improvements for Parkinson’s disease sufferers.

Both new trials will be run over 52-weeks, will include control groups and be double-blinded, thus reducing the potential for placebo effect. Recruitment for the Canadian trial kicks off in January 2022, while the new Adelaide trial, which includes a separate exercise plus treatment group, is scheduled to begin in March 2022. “These two latest trials build on the work we have already started and will test approximately 100 patients,” said SYMBYX CEO, Dr Wayne Markman. “They are designed to gauge and analyse the impact of photobiomodulation. Our first two clinical trials showed significant improvements in patients suffering from Parkinson’s. We believe the new trials will lead to further commercial applications in additional countries,” Dr Markman said. The Canadian trial results will form the foundation of an FDA approval for SYMBYX. The therapy already has regulatory approval in the UK, EU, Australia & NZ (www.symbyxbiome.com).

Patients treated by SYMBYX co-founder and Sydney University Adjunct Senior Lecturer, Dr Ann Liebert, have returned to playing the piano, report being able to shop, carry groceries and also garden more easily. Some have even had a return of their sense of smell. “This is critical research into what historically has been an intractable, neurodegenerative condition that typically doesn’t improve,” Dr Markman said. “The best results are achieved in conjunction with a healthy diet, regular exercise, a realistic approach to treatment and care from qualified practitioners and supportive family members.”

According to the BMC Neurology manuscript, ‘measures of mobility, cognition, dynamic balance and fine motor skill were significantly improved with treatment for 12 weeks and up to one year. PPL reported that PBM was shown to be an effective treatment for a number of clinical signs of PD, with some being maintained for 45 weeks, despite lockdown restrictions.’ Improvements reported were similar between both studies.

Parkinson’s is currently incurable. It is a progressive neurological condition caused by a lack of dopamine, a chemical produced by the brain to help initiate and control body movement. Symptoms include muscle rigidity, tremor, difficulty walking as well as depression, anxiety, compromised swallowing and loss of sense of smell. It affects between 12 and 15 million people worldwide and is more prevalent than prostate, bowel and many other forms of cancer. It is the world’s fastest growing neurodegenerative disorder.

Photobiomodulation works in several ways to reduce Parkinson’s symptoms:

• it targets cell mitochondria, where the energy units (known as ATP) driving all human life is produced - fatigue is a common symptom of Parkinson’s;
• ion channels in nerves are modulated downwards resulting in reduced chronic pain associated with muscle spasm and rigidity;
• systemic inflammation is reduced through the metabolism of anti-inflammatory bio-markers; and
• additional neuro-transmitters, already in short supply in a Parkinson’s model, are manufactured in the gut – over half our Dopamine and c. 85% of serotonin is  manufactured in the colon. This typically has a very positive cognitive effect (reducing ‘brain fog’ while improving sleep, speech, mood and initiative). Motor improvements include balance, gait and fine motor control such as handwriting. 

SYMBYX was formed in 2019 to commercialise therapies, initially for Parkinson’s Disease. Other possible applications include further neurological disorders - Alzheimer’s, autism and depression, as well as IBS, metabolic syndrome and cardio-vascular disease.

 

“There is a quickly growing body of peer-reviewed research and a new clinical appreciation for and understanding of the aetiology of chronic diseases,” Dr Markman said. “The gut-brain, gut-kidney and gut-heart axis are absolutely fundamental to treating chronic disease. Our microbiota (the families of billions of bacteria, viruses and other microbes sharing our intestinal tracts) influence our general health and mental well-being.” 

Early-round investors in SYMBYX include leading biomedical, medical device and venture capital investors. The company will likely commence a further round of capital raising in the US later this year.

 

Dr Markman, CEO, is available for interview.

For media inquiries, call Michelle Innis on +61 414 999 693

P&L Corporate Communications

 

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International neurology journal notes positive improvements in Parkinson’s trial: SYMBYX

August 2021

SYMBYX, an Australian med-tech company developing laser light therapies to reduce Parkinson’s symptoms, said it welcomed the publication of key findings from its Adelaide clinical trial in the leading BMC Neurology Journal.

The journal published results of the 52-week trial involving two groups of patients that showed improvements across a range of motor and non-motor skills. Parkinson’s South Australia (PSA) partially funded the trial.

The trial involved the use of light therapy, known as photobiomodulation (PBM), which is being investigated by SYMBYX to treat a range of neurodegenerative conditions, the most notable and promising of which is the management of Parkinson’s symptoms.

Dr Ann Liebert, SYMBYX’s chief scientist and adjunct senior lecturer at the Department of Medicine at the University of Sydney, coordinated the trial. SYMBYX chief executive Wayne Markman said the trial showed that PBM therapy is capable of improving symptoms.

Parkinson’s disease is a currently incurable, progressive neurological condition caused by a lack of dopamine, a chemical produced by the brain to help initiate and control body movement. Symptoms can include muscle rigidity, tremor, difficulty walking as well as depression, anxiety, difficulty swallowing and loss of sense of smell.

It affects between 10 and 15 million people worldwide. It is more prevalent than prostate, bowel and many other forms of cancer and the total number of Parkinson’s sufferers is four times the number of people suffering with MS.

“Parkinson’s disease is now the world’s fastest growing neurological disease,” Dr Markman said. “This is a promising trial that provides a clear impetus for additional higher-level trials.”

The SYMBYX trial, conducted in Adelaide with Parkinson’s SA, involved two small groups of patients, all diagnosed with Parkinson’s disease by a neurologist. Participants used the laser light device in a clinical setting for 12 weeks, and then a further 40 weeks from home.

Patients were assessed before the trial started and again through the year-long treatment period. The devices used were medical-grade lasers, containing diodes manufactured in Sweden under exclusive licence to SYMBYX.

The trial aimed to assess the effectiveness of PBM to mitigate clinical signs of Parkinson’s disease, in a prospective proof-of-concept study. It is a precursor to a larger randomized placebo-controlled trial (RCT), to be conducted later this year.

The results, published in the BMC Neurology journal, found that measures of mobility, cognition, dynamic balance and fine motor skill were significantly improved with PBM treatment for 12 weeks and up to one year.

“Many individual improvements were above the minimal clinically important difference, the threshold judged to be meaningful for participants,” the research states. “Individual improvements varied but many continued for up to one year with sustained home treatment. No side effects of the treatment were observed.”

The journal also noted that: “PBM was shown to be a safe and potentially effective treatment for a range of clinical signs and symptoms of PD. Improvements were maintained for as long as treatment continued, for up to one year in a neurodegenerative disease where decline is typically expected.

“Home treatment of PD by the person themselves or with the help of a carer might be an effective therapy option. The results of this study indicate that a large RCT is warranted.”

“SYMBYX is about to start preparations for the next big trial, a randomized placebocontrolled trial with a longer follow-up period,” he said.

The Adelaide study importantly noted no adverse side effects and that PBM was shown to be “a safe and potentially effective treatment”.

SYMBYX devices use non-thermal (heating) laser lights directed to the patient’s gut to promote increased dopamine production. “What most people don’t know is that about half of our dopamine actually comes from the gut,” Dr Markman said. “Using SYMBYX hand-held lasers and treatment protocols, patients are able to stimulate their gut microbiome to take over and do some of the heavy lifting, in terms of dopamine manufacturing,” he said.

A full copy of the BMC Neurology Journal report can be found here.

Dr Markman is available for interview. For media inquiries, call Michelle Innis on +61 414 999 693 at P&L Corporate Communications