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news.Kainos Medicine has started phase 1 clinical trials of its Parkinson's Disease drug candidate code-named KM-819.
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The Company has now dosed their first human subject with KM-819, an orally active small molecule that is a potentially disease-modifying treatment of Parkinson's Disease. The trial is taking place in South Korea.
This Phase 1 randomized, double-blind, placebo-controlled study is divided into Part A (Single Ascending Dose) and subsequently Part B (Multiple Ascending Dose), and will evaluate the safety, tolerability, and pharmacokinetics as well as various pharmacodynamics markers of KM-819 in healthy volunteers.
A total of 48 people will be enrolled in the initial stages of Part A, including 8 elderly.
KM-819 has shown superior efficacy in neuroprotection in cell models, and in dopaminergic neuron protection in the midbrain of various animal models of Parkinson's disease as well as improvement in behavioral tests, suggesting the drug has the potential capability of slowing or stopping the progression of Parkinson's Disease.
KM-819 is a small molecule developed as an inhibitor for FAF1, a proapoptotic protein, designed to target various degenerative diseases. It has shown superior neuroprotective efficacy in Parkinson's disease models, and recently entered into the clinical trial phase, aiming to prove its efficacy in stopping the disease in human patients. The efficacy of KM-819 may be also explored for other degenerative diseases.
About Parkinson's Disease
Parkinson's Disease is a very common disease of the Central Nervous System (CNS),second only to Alzheimer Disease in the number of people diagnosed with an estimated 6 to 10 million patients worldwide, 1 million of whom are in the United States. It is more common in elderly people and affects 2-3% of those aged 65 and over, with an increase expected as the population continues to age.
The current standard of care is limited to supportive symptom management with supplemental dopamine or dopamine agonists or analogous mechanisms; a disease modifying treatment is one of the most urgent needs in order to counter the otherwise inevitably growing impact of Parkinson's Disease.
