KainosMed Receives US FDA Approval for Parkinson's Disease Treatment Phase 1b Clinical Trial

[Asia Economy Reporter Hyunseok Yoo] Kainosmed announced on the 25th that the U.S. Food and Drug Administration (FDA) has approved the clinical trial application (IND) for the Parkinson's disease treatment (KM-819) submitted through its subsidiary Fascinate Therapeutics.

The FDA, which usually takes about a month for review, completed it in just three weeks and approved the Phase 1b trial. The company explained that this fully recognizes the safety established in the Phase 1 trial conducted domestically and the toxicity tests in animals.

The company plans to start recruiting clinical trial participants next month at the Paraxel Clinical Center in California, USA, and begin the trial as early as January next year.

Kainosmed introduced a new formulation with significantly improved drug absorption (bioavailability) compared to the previous formulation used in Phase 1. Through this Phase 1b trial, they will determine the dosage of the new formulation to be used in Phase 2, as well as compare it with the previous formulation.

This Phase 1b trial will be conducted over one month with eight healthy adult males. The same subjects will first be administered the existing formulation, followed by the new formulation, to measure the absorption of the KM-819 drug.

Meanwhile, Kainosmed plans to complete the Phase 2 protocol early so that the Phase 2 IND submission can be made promptly after the completion of Phase 1b.