KL1333 clinical trial : Swedish biotech company NeuroVive Pharmaceutical has wrapped up recruitment of healthy volunteers in the second part of its ongoing phase Ia/b clinical trial for its drug candidate drug KL1333 for the chronic oral treatment of primary mitochondrial disease.
According to NeuroVive Pharmaceutical, the first part of the clinical study assessed the impact of food intake on the uptake of KL1333 following a single dose in healthy volunteers. The study yielded promising drug properties and safety data, said the Swedish biotech company.
In the second part of the KL1333 clinical trial, five cohorts of healthy volunteers were subjected to multiple ascending doses.
NeuroVive Pharmaceutical said that it will initiate the third and final part of the clinical study after completing the evaluation of results from the two first parts. In the third part of the KL1333 clinical study, repeated doses of the drug candidate will be administered to primary mitochondrial disease patients.
Considered to be metabolic diseases, primary mitochondrial diseases impact the ability of cells to convert energy and can result in severe symptoms like heart failure and rhythm disturbances, mental retardation, dementia, movement disorders, vomiting and seizures, stroke-like episodes, blindness, deafness, and limited mobility of the eyes.
Commenting on the KL1333 clinical trial, Magnus Hansson – Chief Medical Officer and Vice President Preclinical and Clinical Development at NeuroVive Pharmaceutical said: “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.”
The ongoing KL1333 clinical study, which is being held in the UK, will study the safety and pharmacokinetics of the primary mitochondrial disease drug candidate. Apart from that, biomarkers and functional measures will be assessed, said the Swedish biotech company.
Erik Kinnman – CEO of NeuroVive Pharmaceutical, commenting on the KL1333 clinical trial, said: “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.”
KL1333 is said to be capable of modulating the cellular levels of NAD+, a central co-enzyme in the cell’s energy metabolism. In preclinical models, KL1333 is said to have shown its ability to boost mitochondrial energy output, bring down lactate accumulation, and lessen the formation of free radicals and to have long-term beneficial effects on energy metabolism like the formation of new mitochondria.