The first patient has been dosed in a two-part Phase 1 clinical trial evaluating KM-819, Kainos Medicine’s potential disease-modifying treatment for Parkinson’s disease (PD), the company announced in a press release.
The dose-escalation clinical trial (NCT03022799) will evaluate the drug’s safety, tolerability, and biochemical properties following single and multiple oral doses of KM-819 in 48 healthy adults, of whom eight are elderly.
In Part A, a single dose of KM-819 or a placebo will be given in ascending doses to participants. Part B will evaluate the same properties in multiple ascending doses of the compound, as well as various biochemical and physiologic effects of KM-819 in healthy volunteers.
The trial’s co-primary endpoints are the assessment of adverse events and prior or current medication that study participants are taking other than KM-819. Both endpoints will be evaluated through the end of the study, around six weeks)
More information about this clinical trial, which is being conducted in CHA Bundang Medical Center in South Korea, can be found here.
In preclinical studies, KM-819 has shown superior effectiveness in neuroprotection in cell models and in dopaminergic neuron protection in the midbrain of animal models of Parkinson’s. The drug has also been shown to improve behavioral tests.
Kainos believes the compound may potentially slow or even stop the progression of Parkinson’s, a disease that affects about 1 million patients in the U.S. and an estimated 6 to 10 million patients worldwide, according to the Centers for Disease Control and Prevention (CDC). Parkinson’s is the second most common neurodegenerative disease, with a prevalence that increases with age.
KM-819 is an innovative new drug based on the mode of action that protects dopaminergic neurons from death by inhibiting the function of proapoptotic (pro-cell death) protein called FAF1, which is known to induce cell death. Kainos Medicine is also planning to explore KM-819 for other degenerative diseases.