LUND, Sweden, Dec. 20, 2019 /PRNewswire/ -- NeuroVive
Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX:
NEVPF) today announced the completed recruitment of
healthy volunteers in the second part of the company's ongoing
Phase Ia/b clinical study with candidate drug KL1333, in
development for chronic oral treatment of primary mitochondrial
disease.
The first part of the study, in which the effect of food intake on
the uptake of KL1333 after a single dose had been assessed in
healthy volunteers, showed promising drug properties and safety
data. In the second part of the study, five cohorts of healthy
volunteers received multiple ascending doses.
After evaluation of results from the two first parts of the study,
the third and final part will be initiated. In this part, repeated
doses of KL1333 will be given to patients with primary
mitochondrial disease.
"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", said Magnus Hansson, Chief Medical Officer and Vice
President Preclinical and Clinical Development at NeuroVive.
The focus of the ongoing study, conducted in the UK, is to evaluate
safety and pharmacokinetics of KL1333. In addition, biomarkers and
functional measures will be assessed.
"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", said NeuroVive's CEO
Erik Kinnman.
The information was submitted for publication, through the agency
of the contact person set out below, at 3:15
p.m. CET on 20 December
2019.
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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About primary mitochondrial diseases
Primary 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 primary mitochondrial disease. Primary
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. The candidate
drug is intended for chronic oral treatment of primary
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 chronic
treatment of primary mitochondrial diseases and one project, in
preparation for clinical trials (NV354), for treatment of primary
mitochondrial diseases with Complex I deficiency. NeuroSTAT for
traumatic brain injury (TBI) is ready to enter a clinical phase II
efficacy study. The R&D portfolio also consists of early
projects for primary mitochondrial disease, and NASH. NeuroVive's
ambition is to take drugs for primary mitochondrial diseases
through clinical development and all the way to market, with or
without partners. For the TBI and NASH projects the goal is to
enter strategic partnerships. 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).
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NeuroVive completes recruitment in the second part of its ongoing
KL1333 clinical Phase Ia/b study
https://news.cision.com/neurovive-pharmaceutical/i/patient-sang-liten,c2731000
Patient sang liten
