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Kainos Medicine asks FDA to meet on Parkinsonism treatment
  • By Lee Han-soo
  • Published 2020.03.18 17:07
  • Updated 2020.03.18 17:07
  • comments 0

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.


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