NeuroVive Pharmaceutical AB and Yungjin Pharm announced that the phase I clinical study in Korea within the companies' joint project KL1333, an investigational treatment for genetic mitochondrial disorders, including MELAS (Mitochondrial Myopathy, Encephalopahty, Lactic Acidosis and Stroke-like episodes), is proceeding according to plan. The first part of the study has been successful. The pharmacokinetic data was in line with expectations and no adverse safety signals were detected.

The study's remaining higher dose-cohorts have now been approved by the Korean medicinal authority, the Ministry of Food and Drug Safety (MFDS). The study is a double-blind, placebo-controlled, single-dose, dose-escalation phase I clinical study to investigate the pharmacokinetics, safety and tolerability of KL1333 in healthy volunteers. The first part of the study included dose levels of 25 mg and 50 mg.

With both doses having been deemed safe, the MFDS has approved dose escalation and an updated study design. A multiple-dose, phase Ib study, sponsored by NeuroVive, is planned to be initiated in Europe and/or the U.S. in 2018.