default_top_notch
default_news_top
default_news_ad1
default_nd_ad1

Kainos Medicine asks FDA to meet on Parkinsonism treatment

Lee Han-soo  Published 2020.03.18  17:07  Updated 2020.03.18 17:07

공유
default_news_ad2

Kainos Medicine said that it has made a request to the U.S. Food and Drug Administration for a pre-investigational new drug application (pre-IND) meeting for KM-819, a Parkinson's disease treatment candidate.

The company hopes it could hold the meeting in May, and receive a final review from the FDA before it submits official IND application.

KM-819 is a substance that has shown potential as a treatment for Parkinson's disease. The company has confirmed the candidate’s neuroprotective effect and the improvement of behavioral impairment symptoms in a 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) animal model.

The company completed the phase 1 clinical trial of treatment in Korea in March 2018, confirming the treatment's safety, tolerability, and pharmacokinetic properties. Kainos Medicine has since been preparing for phase 2 clinical trials in the U.S. based on the results in Korea while planning to introduce a new biomarker for patients with the enteric nervous system (ENS) during the phase 2 trials.

corea022@docdocdoc.co.kr

<© KBR , All rights reserved.>
default_news_ad5
default_news_bottom
default_nd_ad4
default_bottom
#top
default_bottom_notch