NeuroVive Pharmaceutical has received approval of its clinical trial application concerning a planned phase I KL1333 study in patients and healthy volunteers from the UK regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA).
KL1333 is a first-in-class NAD+modulator in clinical development for chronic oral treatment in genetic mitochondrial diseases.
The primary purpose of the study is to investigate the pharmacokinetics, safety and tolerability of KL1333 in healthy volunteers and thereafter in patients with genetic mitochondrial disease. The study will be conducted in the UK and is planned to start in Q4 2018.
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The study includes an assessment of a single dose in healthy volunteers, to bridge to the previously conducted single ascending dose study in South Korea, completed earlier this year, and furthermore an assessment of the effect of food intake. The study will also include a multiple ascending dose part in healthy volunteers, and in patients with genetic mitochondrial disease.
"MHRA approval is an important milestone ahead of the initiation of our study. It also verifies the quality of the work we have done during the planning and design stage. The study will bring us an important step closer to our goal of bringing a novel treatment opportunity to patients with severe mitochondrial disease with few or no treatment options," said Magnus Hansson, Chief Medical Officer and Vice President Preclinical and Clinical Development at NeuroVive.