Clinical Trials

Date: 2017-06-27

Type of information: Recruitment of the first patient

phase: 1

Announcement: recruitment of the first patient

Company: Neurovive Pharmaceutical (Sweden) Yungjin Pharm (South Korea)

Product: KL1333

Action mechanism:

NAD+ modulator. KL1333 is a potent modulator of the cellular levels of NAD+, a central coenzyme in the cell’s energy metabolism. KL1333 has in preclinical studies been demonstrated to increase mitochondrial energy output, reduce lactate accumulation, diminish the formation of free radicals, and to have long-term beneficial effects on energy metabolism. It is in clinical development stage for chronic oral treatment of primary genetic mitochondrial disorders such as MELAS, KSS, CPEO, PEO, Pearson, MERRF and Alpers syndrome. It’s mode of action is complementary to that of Neurovive's NVP015, which is intended to alleviate acute episodes of energy crises in genetic mitochondrial disorders with dysfunction in respiratory complex I and to Neurovive's NVP025, intended to protect the mitochondria in skeletal muscle from dysfunctional calcium handling and consequential muscle wasting.
On 2 May 2017, Yungjin Pharm granted NeuroVive exclusive global rights to develop and commercialize KL1333, except in Korea and Japan, where Yungjin Pharm retains full rights. Both companies will continue to develop KL1333 in their respective markets, primarily for the treatment of genetic mitochondrial disorders.

Disease: genetic mitochondrial diseases

Therapeutic area: Rare diseases - Genetic diseases

Country: South Korea

Trial details:

The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose. (NCT03056209)

Latest news:

• On June 27, 2017, NeuroVive Pharmaceutical and Yungjin Pharm announced that the clinical phase I study of KL1333 has started in Korea and that the first healthy volunteer has been enrolled. The study is a double-blind, placebo-controlled, single-dose, dose-escalation phase I clinical study to investigate the pharmacokinetics and safety/tolerability of KL1333 in healthy subjects. The study is planned to encompass a total of 60 healthy volunteers and will be fully performed by Yungjin Pharm. KL1333 is in development for the treatment of genetic mitochondrial diseases, such as MELAS and Kearns-Sayre syndrome, for which there are no current medicines. The principal investigator for the study is Professor Kyung-Sang Yu MD, PhD at the Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine. NeuroVive plans to initiate a complementary European and/or US based phase I study in early 2018.