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Parkinson’s Disease

Parkinson’s disease is a progressive neurodegenerative disorder of the central nervous system that mainly affects the patient’s motor function due to reduced dopamine levels in the brain. In early phase, the symptoms of the disease are shaking, rigidity, slowness of movement, and difficulty with walking. Thinking and behavioral problems may also occur. In the advanced stages of the disease, dementia and anxiety are common with other symptoms including sensory, sleep, and emotional problems.

[Disease modifying]

Peptron has developed a sustained release formulation of exenatide (PT302), for example, once weekly or once every two weeks injectable forms which already tested in type 2 diabetic patients. In 2014, Peptron licensed in the exclusive right of the National Institutes of Health(NIH) patent for the use of GLP-1 agonists for the treatment of neurodegenerative diseases including Parkinson’s disease and has been focused on the clinical development of PT302.

The manufacturing facility was constructed in 2018 which will produce the investigational medical product for the Phase 2 clinical with Parkinson’s disease. To strengthen intellectual properties rights, Peptron has collaborated with NIH to produce more patents and publications supporting the scientific background of the use of GLP-1 agonists in CNS fields.

We believe PT302 holds potential to slow the progress of the disease itself, not merely mitigate the symptoms. In addition, it will provide the expansion of indications to the most of CNS disorders including AD, and patient compliances.

[Mode of Action]

Recently, University College London researchers found that Parkinson’s patients treated with an approved diabetes drug, exenatide, did better on movement tests than did patients who received a placebo. The researchers followed 60 patients with Parkinson’s disease, who injected themselves once a week with either exenatide or a placebo, while still taking their existing medications for 48 weeks. The patients were then taken off their treatment temporarily so the researchers could gauge how their disease was progressing. The exenatide group performed better on motor tests-which measured factors such as tremors, agility and speech-than did the placebo group, both at 48 weeks and at a 12-week follow-up. The findings are published in The Lancet.

Fig 1. Mechanism of neuroprotective effect of GLP-1R agonists

[Stage & Epidemiology]

There are three main stages of Parkinson’s disease: mild, moderate and severe. Patients suffering from moderate to severe Parkinson’s disease constituted 60% of all Parkinson’s disease patients in 2011. PD affected 6.2 million people and resulted in about 117,400 deaths globally in 2015. Parkinson's disease typically occurs in people over the age of 60, of which about one percent is affected and is one of the huge burdens on healthcare system with medical unmet needs.

[Treatment & unmet medical needs]

The cause of Parkinson's disease is generally unknown and as a result, there is no cure for Parkinson's disease, with treatment directed at improving symptoms. The typical treatment of Parkinson’s disease is the anti-Parkinson medication levodopa (L-DOPA) with dopamine agonists being used once levodopa becomes less effective. As the disease progresses and neurons continue to be lost, these medications become less effective while at the same time they produce a complication marked by involuntary writhing movements. Because current treatments focus on relieving symptoms, such as tremors and slowness of movement, but do not hinder or halt the disease’s progression, the development of the disease modifying treatment is highly encouraged to promote the quality of patient’s quality of life.

Fig 2. The need for disease modifying treatment

[Market size and Growth & Competition]

The Parkinson’s disease treatment market is expected to grow from USD 4.24 billion in 2017 to USD 5,694.1 million in 2022, it grows at a CAGR of 6.1%.(source: reportsnreports)

Currently, 2 investigator initiated trials using GLP-1 agonists (lixisenatide and liraglutide) are recruiting PD patients in collaboration with CPT and VARI in France and US respectively, which will prove and support the efficacy of the GLP-1R pathway in PD.

[Reference]

1. Athauda, Dilan, Kate Maclagan, Simon S Skene, Martha Bajwa-Joseph, Dawn Letchford, Kashfia Chowdhury, and Steve Hibbert et al. 2017.

"Exenatide Once Weekly Versus Placebo In Parkinson's Disease: A Randomised, Double-Blind, Placebo-Controlled Trial". The Lancet 390 (10103): 1664-1675. doi:10.1016/s0140-6736(17)31585-4.

2. Kim, Dong Seok, Ho-Il Choi, Yun Wang, Yu Luo, Barry J. Hoffer, and Nigel H. Greig. 2017.

"A New Treatment Strategy For Parkinson's Disease Through The Gut-Brain Axis" Cell Transplantation 26 (9):1560-1571. doi:10.1177/0963689717721234.