Policy & Regulation
NeuroVive Pharmaceutical announces receipt of KL1333 clinical trial regulatory approval from MHRA in UK
10 October 2018 -

Mitochondrial medicine company NeuroVive Pharmaceutical AB (STO:NVP) announced on Wednesday the receipt of 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.

Reportedly, 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. This study will be conducted in the UK and is planned to start in Q4 2018.

According to the company, this 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 the study.

It also verifies the quality of the work the company has done during the planning and design stage, the company added.