NeuroVive Pharmaceutical has announced the completed recruitment of healthy volunteers in the second part of the company’s ongoing Phase Ia/b clinical study with candidate drug KL1333, in development for chronic oral treatment of primary mitochondrial disease.
The first part of the study, in which the effect of food intake on the uptake of KL1333 after a single dose had been assessed in healthy volunteers, showed promising drug properties and safety data. In the second part of the study, five cohorts of healthy volunteers received multiple ascending doses.
After evaluation of results from the two first parts of the study, the third and final part will be initiated. In this part, repeated doses of KL1333 will be given to patients with primary mitochondrial disease.
“We look forward to be able to start the exciting final part of the study where KL1333 for the first time will be given to patients with primary mitochondrial disease”, said Magnus Hansson, Chief Medical Officer and Vice President Preclinical and Clinical Development at NeuroVive.
The focus of the ongoing study, conducted in the UK, is to evaluate safety and pharmacokinetics of KL1333. In addition, biomarkers and functional measures will be assessed.
“During the first half of next year we also plan to initiate a natural history study in primary mitochondrial disease patients as part of our Phase II program, as a bridge to our clinical efficacy study, to optimize the patient selection criteria and use of endpoints. These are important steps in the opportunity of developing KL1333 towards a life changing treatment for patients with primary mitochondrial disease”, said NeuroVive’s CEO Erik Kinnman.
Photo of Erik Kinnman