KainosMed Submits Pre-IND Application to US FDA for Parkinson's Disease Treatment

[Asia Economy Reporter Hyunseok Yoo] Kainosmed, which is pursuing a merger listing with Hana Financial No.11 SPAC, announced on the 18th that it has applied for a Pre-IND (Investigational New Drug application) meeting with the U.S. Food and Drug Administration (FDA) for its Parkinson's disease treatment (KM-819).

Kainosmed expects the meeting with the FDA to take place in May through this application, and through this meeting, it plans to receive a final review of the submitted materials from the FDA official before the IND application.

KM-819 is a substance that has demonstrated neuroprotective efficacy and improvement in behavioral inhibition symptoms in the MPTP animal model, indicating its potential as a treatment for Parkinson's disease. In March 2018, Kainosmed successfully completed Phase 1 clinical trials of KM-819 in Korea, confirming its safety, tolerability, and pharmacokinetic properties.

Based on preclinical and Phase 1 clinical data, the company has been preparing for Phase 2 clinical trials in the United States. Following the advice of Dr. Carolyn Ballow, an authority in Parkinson's disease clinical development, the clinical trial period was set to two years, and a nine-month long-term toxicity study in animals was completed to secure excellent safety. Additionally, a new biomarker for patients with enteric nervous system (ENS) abnormalities will be introduced for the first time in the clinical trial.

Kainosmed has virtually completed the Phase 2 clinical trial protocol together with Parexel, a global contract research organization (CRO) headquartered in the U.S., and Dr. Ballow, and is striving to apply for the Phase 2 IND for the Parkinson's disease treatment after the Pre-IND meeting.

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