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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