SYMBYX announces promising Sydney Adventist Hospital clinical trial results for Parkinson's using the SYMBYX Neuro - a new light therapy wellness helmet

SYDNEY,March 17,2023 -- SYMBYX,an Australian medtech company developing light therapies for intractable disease conditions,today announced the results of a Sydney Adventist Hospital (commonly known as the San) triple-blinded,randomised controlled trial investigating the effects of a new red/infrared light therapy helmet on patients living with Parkinson's Disease.

The trial,coordinated by the San,was conducted remotely (ie,at home) under the supervision of a clinical team including the San Director of Research and Neurologist,Dr Geoffrey Herkes (MBBS,PhD,FRACP).

The trial investigated the efficacy of a new red/infrared light therapy helmet (called the SYMBYX Neuro) on patients living with Parkinson's Disease. Trial participants were split into two groups of 20 each,with one group receiving active treatment and the other a placebo infrared helmet therapy. Infrared light therapy is invisible to the naked eye and painless to receive. All placebo patients subsequently received active treatment (after the initial 12 weeks plus an additional four week washout period).

"The San trial is the first of its kind in the world with a control group." said SYMBYX Chief Executive Dr Wayne Markman.

"COVID made data collection significantly more challenging but the scientists did a fantastic job. This research confirms that transcranial light therapy is an effective complementary therapy for reducing Parkinson's symptoms," Dr Markman said.

The standardised Parkinson's Disease Rating Scale (MDS-UPDRS-III) was used to rate patient improvements,with a baseline test conducted on each patient before starting treatment,followed by a second test after 12 weeks of treatment.

The trial recorded results across five sub-categories of motor tests over a 12-week period.The group with the active treatment improved 24-58 percent over baseline across all five areas tested,unlike the placebo group which showed a statistically valid improvement in lower limb coordination and movement only.

The five areas tested included:

facial expression

upper limb coordination & movement

lower limb coordination & movement

walking gait

tremor

The following table summarizes the results of medium to strong responders across the Active treatment and Placebo groups. 70% of Active participants and 55% of Placebo responders were identified as medium to strong responders.

Sub-Category

Description

Active Treatment

(% Improvement

over Baseline)

Placebo Treatment

(% Improvement (3)

Over Baseline)

1. Facial Expression

observe eye-blink frequency,masked faces or

loss of facial expression,

spontaneous smiling,and parting of lips

27%

Not statistically meaningful

2. Upper Limb

combination of finger tapping (index to thumb),

hand movement (open/close fist),

and pronation-supination movements of hand

40%

Not statistically meaningful

3. Lower Limb

combination of toe tapping,leg agility (place foot on the ground,

raise foot and stomp)

and arising from the chair (arms crossed)

58%

58%

4. GAIT

observe for start hesitation,stuttering movements when turning.

Patient to walk away from and towards examiner at least 10 meter.

Observe stride amplitude,stride speed,height of foot lift,heel strike,

turning,arm swing,freezing

28%

Not statistically meaningful

5. Tremor

test for resting,postural and kinetic

(finger-to-nose manoeuvre) tremour

24%

Not statistically meaningful

(1) Under review by leading peer reviewed journal. Only study responders are shown above – ie,those showing a moderate to strong positive response.

(2) Information only reflects "responders" which amounts to approximately 70% of all subjects in the trial,receiving active treatment with the SYMBYX Neuro helmet and exhibiting a moderate to significant clinical response.

(3) Statistical significance was determined with a P value of <= 0.05 in a Paired T-test analysis.

"There is clearly a placebo effectfrom using light therapy on some patients,but not on all," said Dr Herkes.

"Furthermore,one would expect the positive effect of using a sham helmet to diminish over time. We look forward to reporting on more data from this trial in the coming months."

"If you consider the sub-category results,however,then the positive benefits of active helmet light therapy become clearer," Dr Herkes said.

Parkinson's is currently incurable. It is a progressive neurological condition caused by a lack of dopamine,a chemical used 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. In addition to the 12million people diagnosed worldwide (which excludes numbers from India and China),it is estimated that three to four times more people have undiagnosed early signs and symptoms. Parkinson's is now the world's fastest-growing neurodegenerative disorder.

Light therapy (often referred to as Photobiomodulation),works in several ways to reduce Parkinson's symptoms:

Targeting cell mitochondria,where chemical energy known as ATP,driving all human life,is produced. Low energy or fatigue is a common symptom of Parkinson's.

Targeting the gut where neuro-transmitters,in short supply in Parkinson's,are manufactured. Over 50 percent of our dopamine and 85 percent of our serotonin is produced in the gut. Light therapy 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.

Modulating ion channels in nerves resulting in reduced pain associated with muscle spasm,rigidity and postural problems;

Reducing systemic inflammation through the production of anti-inflammatory biomarkers.

People living with Parkinson's who have used light therapy on their gut and/or transcranially,have returned to activities they previously enjoyed such as playing the piano,shopping,carrying groceries and also gardening more easily. Some have also had improvements in their sense of smell,digestion,sleep and energy levels.

"This San trial of the new SYMBYX Neuro light therapy helmet is critical research in Parkinson's. PD has historically been an intractable,neurodegenerative condition that typically declines with no improvements possible,whereas the SYMBYX Neuro users showed improvement across all measures," Dr Markman said.

"Importantly,light therapy does not interfere with other Parkinson's treatments,including medications. And the best results are always achieved in conjunction with a healthy diet,regular exercise,a realistic approach to treatment and support from qualified practitioners and caring friends or family members," he said.

Earlier trials conducted in Adelaide (published in BMC Neurology UK,2021) and Sydney (published in Photobiomodulation,Photomedicine and Laser Surgery,2022),showed significant reductions in patient symptoms. 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.

An abstract on the trial has been accepted by the American Academy of Neurology (ANN),and Dr Herkes will present it in person in Boston at the AAN's annual meeting from 22-27 April.

Interviews

Dr Markman,SYMBYX CEO,and Dr Geoffrey Herkes are available for interview.

For media inquiries,contact Ian Pemberton at P&L Corporate Communications in Sydney on +61 414 999 693