KainosMed Officially Begins Phase 2 Trial of Parkinson's Disease Treatment in the US

[Asia Economy Reporter Chunhee Lee] Kainosmed announced on the 12th that it has started dosing for the Phase 2 clinical trial of the Parkinson's disease treatment 'KM-819' in the United States.

This clinical trial, which is being fully launched about eight months after the U.S. Food and Drug Administration (FDA) approved the Phase 2 clinical trial plan (IND) last November, will be conducted in two stages. The first stage, starting early next month, will administer KM-819 at doses of 200 mg, 400 mg, and 800 mg to 24 Parkinson's disease patients and 18 healthy participants to determine the optimal dose. In the previous Phase 1 trial, doses up to 400 mg were administered without side effects.

Once the dosage is confirmed, the second stage will begin next year, administering the drug to 288 Parkinson's disease patients in the United States.

Parkinson's disease is a degenerative brain disorder characterized by the gradual death of dopamine-producing nerve cells in the substantia nigra of the midbrain, leading to reduced dopamine levels and causing motor symptoms such as tremors and gait disturbances, as well as cognitive impairments. The pathological hallmark of this disease is the abnormal accumulation of alpha-synuclein in the nervous system, resulting in excessive protein aggregates. According to the global market research firm MARC, the global Parkinson's disease treatment market, which was valued at $6.34 billion (approximately 8.3 trillion KRW) in 2020, is estimated to reach $8.88 billion (approximately 11.6 trillion KRW) by 2026.

However, most current Parkinson's disease treatments only alleviate symptoms and do not halt disease progression, making fundamental therapies urgently needed. Kainosmed differentiates itself by targeting the 'FAF1' protein, which is involved in nerve cell necrosis and apoptosis, with KM-819. The company envisions that by inhibiting the overexpression of FAF1?found to be elevated in the brain tissues of Parkinson's patients compared to healthy individuals?it can suppress nerve cell death and activate the removal of unnecessary cellular components. KM-819 also has a dual effect of inhibiting the accumulation of alpha-synuclein in the brains of Parkinson's patients and protecting dopamine-producing nerve cells. Utilizing this mechanism, Kainosmed is also conducting a Phase 2 clinical trial in South Korea to develop KM-819 as a treatment for multiple system atrophy (MSA), a rare degenerative brain disease.

Jae-moon Lee, CEO of Kainosmed, stated, “We will do our best to complete various clinical trials using KM-819 early and bring good news to patients suffering from this disease.”

This content was produced with the assistance of AI translation services.