KainosMed Applies for IND for Parkinson's Disease Treatment Phase 1b Clinical Trial with US FDA

[Asia Economy Reporter Hyunseok Yoo] Kainosmed announced on the 2nd that its subsidiary, FAScinate Therapeutics, has submitted an Investigational New Drug application (IND) for the Parkinson's disease treatment drug (KM-819) to the U.S. Food and Drug Administration (FDA).

Kainosmed introduced a new formulation with significantly improved drug absorption (bioavailability) compared to the previous formulation used in Phase 1 clinical trials. The Phase 1b trial will be conducted not only to compare with the previous formulation but also to determine the dosage of the new formulation to be used in Phase 2. This Phase 1b trial will be rapidly conducted over one month with eight healthy adult males as subjects.

The new formulation uses the same active pharmaceutical ingredients as the previous one but is completed using a technology called Hot Melt Extrusion, which mixes and melts the active pharmaceutical ingredients and polymers at a momentary high temperature. This method significantly increases pharmacokinetics (PK), especially absorption. The study commissioned to Latitude in the U.S. was successful, and production compliant with FDA regulations was carried out by Bioduro.

Kainosmed explained that there is no issue entering Phase 2 clinical trials because long-term toxicity tests conducted for 6 months in rodents and 9 months in dogs showed no toxicity.

A company official stated, "Although it was possible to proceed with Phase 2 clinical trials using the existing formulation, the successful development of a formulation with improved absorption is expected to provide better efficacy at lower doses and improve medication compliance."

Lee Gisub, CEO of Kainosmed, said, “We are very pleased to connect the clinical trials conducted in Korea to those in the U.S.,” and added, “KM-819, which has proven efficacy not only at Chungnam National University, Seoul National University Bundang Hospital, and Samsung Medical Center in Korea but also at San Diego State University and the Parkinson’s Institute in the U.S., is expected to yield good results going forward.”

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