KainosMed's Parkinson's Disease Treatment Clinical Trial Shows 'Positive Signs'... "No Long-Term Animal Toxicity"

[Asia Economy Reporter Hyunseok Yoo] Kainosmed, a developer of central nervous system (CNS) drugs, announced on the 19th that its Parkinson's disease treatment KM-819 showed "no drug-related toxicity" in long-term toxicity tests on animals for its Phase 2 clinical trial. KM-819 has now met all the conditions to enter Phase 2 clinical trials.

In drug development, side effects are as important as efficacy, and safety must be proven in animals before entering clinical trials. Especially for clinical trials requiring long-term drug administration, toxicity must be tested through long-term drug administration for 9 months in non-rodents such as dogs and 6 months in rodents.

According to the testing organization BTS Research, KM-819 showed "no drug-related toxicity" in tests conducted on 48 dogs and 160 rats. The excellent safety profile of KM-819 has been secured.

The excellent safety of KM-819 suggests that there will be minimal side effects in actual human use. KM-819 has already demonstrated no drug-related side effects during a one-week administration in a previous Phase 1 clinical trial.

A company official explained, "With the success of the long-term toxicity test, we have applied for IND for the US Phase 2 clinical trial as a 'disease-modifying treatment' rather than a symptomatic relief drug. Although it takes a long time to confirm efficacy after administration for Parkinson's disease disease-modifying treatments, based on this test result, we can significantly shorten the overall clinical trial period."

Currently, Parkinson's disease treatments only provide temporary symptomatic relief, and there are no disease-modifying treatments that fundamentally halt disease progression.

The results of this long-term toxicity test will be used not only in the Phase 2 but also in the Phase 3 clinical trials for Parkinson's disease. Additionally, it is significant because it enables direct entry into Phase 2 clinical trials for expanded indications into degenerative rare brain diseases that Kainosmed is currently pursuing. Kainosmed is preparing for the US Phase 2 clinical trial of KM-819 and aims to enter Phase 2 by mid-year.

Meanwhile, Kainosmed recently received approval for a merger listing with Hana Financial No.11 SPAC and is proceeding with the merger process.

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