Many Parkinson’s Patients live with the fear of falling during daily life activities, which can result in severe injuries. Falls are caused by problems in gait (movement) linked to motor impairments like Freezing of Gait (FOG) or Levodopa Induced Dyskinesia (LID). Other disease symptoms causing Falls are cognitive impairment, visual impairment, depression, anxiety and sleep deprivation.
FALL:
AN UNEXPECTED EVENT
IN WHICH THE PERSON
COMES TO REST ON
THE GROUND, FLOOR
OR LOWER LEVEL.
The fear of falling is a serious impediment to move freely and enjoy life. A treatment that reduces Falls would have a high impact on the quality of life of many Parkinson’s Patients and could strongly reduce healthcare costs.
of Parkinson’s Patients fall each year
is the annual cost for hospitalization, medical care and nursing care
Golden Gait Biotech is developing the first pharmaceutical intervention (GGB-1) for the reduction and prevention of Falls and Freezing of Gait (FOG), for which no medicine exist. In a clinical study (phase 2), 45% of Parkinson’s Patients fell less due to taking GGB-1.
This was shown by Prof. Lieberman, medical doctor of Muhammad Ali
(Lieberman A et al. (2019) Front. Neurol. 10 (424), 1-7).
Besides reducing Falls, GGB-1 has shown additional benefits related to improved gait (movement). This could point towards patients feeling safer on their feet.
Freezing Of Gait (FOG) is defined as a brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk. It is one of the most debilitating motor symptoms in patients with Parkinson’s Disease as it may lead to Falls and a loss of independence.
Postural Stability is the ability to control the body position in space for the purpose of movement and balance. It is necessary for maintaining a static position and for assisting body coordination in dynamic position changes.
Trend to improve LID was observed, supported by a significant improvement of LID on ambulation. LID is uncontrolled, involuntary movement associated with levodopa (L-DOPA), used to treat Parkinson’s Disease. It often involves hyperkinetic movements, including chorea, dystonia, and athetosis.
Next to a strong reduction in Falls, GGB-1
is safe & well-tolerated.
90% of subjects tolerated escalation to maximum dose four times a day.
No Serious Adverse Events (SAE) during GGB-1 dose escalation or at maintenance dose.
No nicotine withdrawal symptoms based on MNWS-R (Minnesota Withdrawal Scale-Revised) scale.
GGB-1 has the same incidence of discontinuation as placebo (17%).
Few cases of nausea can be treated with standard drugs.
Golden Gait Biotech is confirming the observations from its previous phase 2 clinical study.
More Parkinson’s Patients will receive GGB-1 drug over a longer period of time, while experienced Parkinson’s Disease clinicians will monitor closely their Fall Frequency and Freezing of Gait (FOG).
The Pedunculopontine Nucleus (PPN) is the putative “Fall prevention center” of the brain.
It provides cholinergic inputs (green arrows) to thalamus, frontal cortex and other parts of the brain affecting gait, balance and cognition.
As PPN degeneration affects the cholinergic system, Fall prevention has been related to the activation of acetylcholine receptors. Golden Gait Biotech investigational drug is a small molecule that activates this receptor.
This receptor activation by GGB-1 is designed to overcome the cholinergic cell loss in the PPN observed in Parkinson’s Patients, probably the most important neurological Parkinson’s defect/degeneration next to dopamine deficiencies.
Golden Gait Biotech has a strong Intellectual Property (IP) portfolio of patents in multiple countries.
Composition and methods
for treatment related to
Falls and Fall frequency in
neurodegenerative diseases
(expiry: 2037)
Issued US patents in revision in Europe and Japan.
Marketing exclusivity for 3
years in US if Falls
Indication is first for a
nicotine product.
Head of Neurology & Group Leader (National Hospital for Paraplegics)
Director & Founder (Pharmaceutical Innovation Services)
