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 Mater Research leads World-First Trial for Bowel Disease 

2 June 2022  

Mater Researchers are a step closer to discovering whether laser light

therapy can reduce Inflammatory Bowel Disease (IBD) symptoms in young
people. 

Mater Research senior researchers Dr Tatjana Ewais and Associate Professor

Liisa Laakso are conducting the ground-breaking trial in collaboration with
Australian medical laser company, SYMBYX. The trial will investigate whether
photobiomodulation (PBM or light therapy) is effective in relieving IBD
symptoms among 28 participants aged between 18 and 35 who are being
treated at Mater Hospital Brisbane.  

IBD is a chronic auto-inflammatory disease

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can cause high levels of fatigue, depression and pain. The group of diseases
that fall under the IBD umbrella include Crohn’s, ulcerative colitis and
indeterminate colitis. 

The trial will investigate if a specific wavelength of light from the PBM device
can reduce inflammation caused by IBD. Researchers will also measure
whether the infrared light can increase the diversity and number of
beneficial bacteria in the gut microbiome.  

Mater Young Adult Health Centre lead psychiatrist Dr Tatjana Ewais said the
clinical trial was a leap in the right direction for young people experiencing
the debilitating effects of IBD. “More than 100,000 Australians are living with
IBD and most of them developed the disease between the ages of 15 and
29,” Dr Ewais said. “We believe this treatment has the potential to
dramatically improve the quality of life of young people by reducing fatigue,
depression, and pain associated with IBD.” 

SYMBYX CEO Dr Wayne Markman said the PBM treatment was a non-
invasive laser therapy that has been successfully used to treat chronic pain
and inflammation as well as reduce certain other symptoms in patients with
Parkinson’s Disease. 

“Previous research has shown the infrared laser treatment improves

mitochondrial function in all cells, boosting their capacity to fight
inflammation,” Dr Markman said. 

“The Therapeutic Goods Administration has recently approved PBM for

treatment of inflammatory conditions and our PDCare Laser is already being
used to treat more than 2,500 patients in Australia, New Zealand, the United
Kingdom, Europe and other parts of the world,” he said. “We have also
conducted two clinical trials in Adelaide and Sydney which showed
improvements in several motor and cognitive skills among people with
Parkinson’s Disease.” 

Dr Liisa Laakso said the Mater trial participants will be treated with 30
minutes of SYMBYX laser therapy every week over 10 weeks. “We will
examine more than 90 samples from SIGN participants before
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to measure inflammatory marker levels, microbiome diversity and

composition,” Dr Laakso said. 

“Trial participants will also be asked to keep a pain diary throughout the trial
and complete questionnaires about fatigue and physical activity. “IBD is a
debilitating condition, and we’re excited to begin this important research
which will provide a clearer understanding of the power of infrared laser
therapy to change the lives of young people affected by it.” 

Jazmine Domagala, 20, was diagnosed with Crohn’s Disease when she was
13 years old and welcomed research into new treatment options for people
with IBD. 

“Crohn’s has affected my day-to-day life for so long – making me always

tired or in pain,” she said. “It’s also very isolating because I make decisions
based on my disease. Unlike most other 20-year-olds I don’t go out drinking
and partying late into the night because I know I will be floored the next
day”. “I’m hoping this trial will help reduce my fatigue and pain which in turn
will help me manage my anxiety and depression. It would be great if this
treatment could help me get a better quality of life.”  

Trial participants have been recruited through Mater Hospital Brisbane.  

The research is funded by SYMBYX and it will run until late 2023. 

Interviews 

Dr Markman, CEO, is available for interview.  

For media inquiries;

Mater Research: Gail Burke – 0421650728 or gail.burke@mater.org.au 

SYMBYX Biome: Michelle Innis on +61 414 999 693 

P&L Corporate Communications 

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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

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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
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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
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common symptom of Parkinson’s;

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• 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. 

______________________________________________________

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

 
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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.
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research into what

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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
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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.”
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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.
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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

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