NeuroVive Pharmaceutical and Yungjin Pharm announces 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).
“We are very excited about the progress of the first KL1333 clinical study. Along with the recent positive opinion on European orphan drug designation, it brings us one step closer to initiating our own clinical phase Ib study, and to our ultimate goal of providing a treatment opportunity to patients with different genetic mitochondrial disorders, where there is a high medical need and in most cases no specific treatments available,” commented Magnus Hansson, M.D., Ph.D., Chief Medical Officer and VP of Preclinical and Clinical Development at NeuroVive.
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.
“The results from the first part of the study are positive and the approval from the MFDS is of crucial importance for KL1333 and the continuation of its global development program. In close collaboration with our partner NeuroVive, we have a great possibility to develop KL1333 into a novel treatment opportunity for patients with genetic mitochondrial disorders, such as MELAS,” said Soo-Hyun Lew, M.D. Executive Director of Development at Yungjin Pharm.
Photo of Erik Kinnman, CEO NeuroVive