LUND, Sweden, 4 July 2019 /PRNewswire/ -- NeuroVive
Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX:
NEVPF) today announced that the company has initiated
the second part in its ongoing Phase Ia/b clinical study with
KL1333, NeuroVive's candidate drug for chronic treatment of genetic
mitochondrial diseases, following successful completion of the
first part.
NeuroVive has now initiated the repeated dosing of healthy
volunteers in the second part of itsPhase Ia/b clinical study of
KL1333. The first cohort of the study, in which the effect of food
intake on the uptake of KL1333 after a single dose was assessed in
healthy volunteers, has been successfully completed and based on
the review of that data it has been decided to continue the second
part of the study, where multiple ascending doses in healthy
volunteers will be evaluated.
The focus of the ongoing study, conducted in the UK, is to
examine the safety profile and the metabolic changes of KL1333 in
healthy volunteers and in patients. The study has an adaptive
design, which means that the number of cohorts and the dose levels
for the cohorts will be modified, on the basis of results from the
previous cohort. This will maximize the information from the
study. The third and final part of the study will evaluate
repeated doses of KL1333 in mitochondrial disease patients, which
will be the first time KL1333 is given to patients.
"We are truly excited about the data from the first cohort
in our clinical study with KL1333. The drug properties and safety
data observed are reassuring and promising as we now proceed into
the second part of the study," said Magnus
Hansson, Chief Medical Officer and Vice President
Preclinical and Clinical Development at NeuroVive.
"The progress in the KL1333 programis a great step towards our
plan of taking the project to a clinical efficacy study next year
and important to our company. Our ultimate goal is to bring this
possible life changing treatment to the market and to patients with
mitochondrial disease, who currently have a high unmet medical
need," said CEO Erik Kinnman.
This information is information that NeuroVive Pharmaceutical
AB (publ) is obliged to make public pursuant to the EU Market Abuse
Regulation. The information was submitted for publication, through
the agency of the contact person set out below, at 2.30 p.m.
CEST on 4 July 2019.
About genetic mitochondrial diseases
Genetic mitochondrial diseases are metabolic diseases that affect
the ability of cells to convert energy. The disorders can manifest
differently depending on the organs affected by the genetic defects
and are viewed as clinical syndromes. An estimated 12 in every
100,000 people suffer from a genetic mitochondrial disease. Genetic
mitochondrial diseases often present in early childhood and lead to
severe symptoms, such as mental retardation, heart failure and
rhythm disturbances, dementia, movement disorders, stroke-like
episodes, deafness, blindness, limited mobility of the eyes,
vomiting and seizures.
About KL1333
KL1333 is a potent modulator of the cellular levels of NAD+, a
central co-enzyme in the cell's energy metabolism. KL1333 has in
preclinical models 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 such as the formation of new mitochondria. It is in
clinical development stage intended to document the use for chronic
oral treatment in primary genetic mitochondrial disorders such as
MELAS, KSS, PEO, Pearson and MERRF. KL1333 is currently being
evaluated in clinical phase I studies and has been granted orphan
drug designation in both the United
States and Europe. KL1333 has been in-licensed from
Yungjin Pharm, a Korean pharmaceutical company.
About NeuroVive
NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine,
with one project in clinical phase I (KL1333) for genetic
mitochondrial diseases and one project in preparation for a
clinical phase II efficacy study for the prevention of moderate to
severe traumatic brain injury (NeuroSTAT®). The R&D portfolio
also consists of projects for genetic mitochondrial disorders, NASH
and cancer. The company advances drugs for rare diseases through
clinical development into the market, with or without partners. For
projects for common indications the goal is out-licensing in the
preclinical phase. A subset of compounds under NeuroVive's NVP015
program has been licenced to Fortify Therapeutics, a BridgeBio
company, for local treatment development of Leber's Hereditary
Optic Neuropathy (LHON). NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is
also traded on the OTCQX Best Market in the US (OTC: NEVPF).
For more information please contact:
Catharina Johansson, CFO, IR &
Communications
+46 (0)46-275-62-21
ir@neurovive.com
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund,
Sweden
Tel: +46 (0)46-275-62-20 (switchboard)
info@neurovive.com
www.neurovive.com
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NeuroVive initiates
second part of its ongoing KL1333 Phase Ia/b clinical
study
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