Kainos Med said it would start phase 2 clinical trials in the U.S. by administering its Parkinson's disease treatment, KM-819, to subjects.
KM-819 is a new drug developed by Kainos Med, which targets FAF, a protein that promotes cell death. It has a dual effect of inhibiting the accumulation of alpha-synuclein, a major cause of Parkinson's disease while protecting dopamine neurons by suppressing excessive FAF1 release.
Subsequently, it suppresses nerve cell death and activates dopamine neurons to remove unnecessary cell components.
The phase 2 clinical trial targeting Parkinson's disease will comprise two sub-phases. The first sub-phase, scheduled to begin in early August, will incrementally administer KM-819 in 200, 400, and 800mg doses to Parkinson's disease patients and general participants to determine the optimal dose.
Once the dose is confirmed, drug administration will begin in 2023 for 288 Parkinson's disease patients in the U.S. in the second sub-phase in what is regarded as one of the largest clinical trials in the world.
Parkinson's disease is a degenerative brain disease that affects cognitive and motor functions, causing hand tremors and walking disorders as dopamine neurons in the substantia nigra of the midbrain gradually die and decrease dopamine concentration. In addition, in Parkinson’s patients, alpha-synuclein accumulates abnormally in the nervous system, resulting in excessive accumulation of protein aggregates.
The global market was $6.34 billion (about 8.53 trillion won) in 2020 and is expected to reach 11 trillion won by 2026.
Kainos Med attended Bio USA 2022 in June to find a partner and transfer the technology of KM-819. In March, Kainos Med acquired a U.S. patent for successfully developing a salt form that increased the solubility of KM-819.
"We have high expectations for the clinical results as the research has been published in a prestigious international journal," Kainos Med President Lee Jae-moon said, "The U.S. clinical trial for Parkinson's disease and the Korean clinical team for multiple system atrophy (MSA) will soon complete clinical trials. Therefore, we hope to deliver good news for patients.”