Building on a growing body of research
showcasing NR as a potential therapeutic strategy for PD, this is
the first clinical study to showcase the safety, tolerability, and
beneficial metabolic effects of high-dose NR at 3,000 mg per
day
ChromaDex Corp. (NASDAQ:CDXC), a global authority on
Nicotinamide Adenine Dinucleotide (NAD+) and healthy aging
research, shares results from a new breakthrough study analyzing
the safety of high-dose nicotinamide riboside (NR) supplementation
on individuals with Parkinson’s disease (PD). This study was part
of the ChromaDex External Research Program (CERP™), which donated
ChromaDex’s patented NR ingredient, Niagen®, the most efficient and
high quality NAD+ precursor, for the advancement of this
research.
In a pioneering development for PD treatment, this landmark
phase I randomized, double-blind clinical study reported in the
peer-reviewed journal Nature Communications by a team of scientists
led by Prof. Charalampos Tzoulis, Haukeland University Hospital and
University of Bergen in Norway, demonstrated that supplementing
individuals with PD with high-dose (3,000 mg daily) Niagen NR was
short-term safe, greatly increased whole blood NAD+ levels,
augmented the NAD+ metabolome, and was associated with a
significant clinical improvement. These results build upon previous
research led by Dr. Tzoulis (Cell Metabolism) and showcase that
supplementation with Niagen NR may be a therapeutic strategy for
PD, pending further research.
With several studies demonstrating the safety and tolerability
of 2,000mg of Niagen NR, this marks a milestone as the first-ever
clinical study to demonstrate the safety, tolerability, and
beneficial effects of high-dose Niagen NR at 3,000 mg per day.
“As the world's leading company in NAD+ research and
commercialization, ChromaDex is proud to announce this
groundbreaking NR-SAFE study from Dr. Tzoulis and his team of
researchers that reveals the potential of Niagen NR as a therapy
for Parkinson's disease. PD affects more than 10 million people
worldwide,” noted Rob Fried, CEO of ChromaDex. “This research not
only demonstrates the safety and tolerability of high-dose Niagen
NR but also highlights its ability to significantly increase NAD+
levels and potentially improve the clinical severity of PD."
PD is a common neurodegenerative disorder largely characterized
by progressive impairments in motor function, including tremors,
stiffness, slow movement, and poor balance, as well as in non-motor
functions, such as abnormal sleep patterns, gastrointestinal
dysfunction, and cognitive impairment, or dementia. Current
treatment options are limited, and there is a pressing need for
innovative approaches to manage the effects of this debilitating
neurodegenerative disorder.
“Results of this study build on previous research conducted by
our lab, demonstrating that oral NR therapy increases NAD+ levels
in the brain of individuals with PD and this is associated with
ameliorated brain metabolism and mild clinical improvement,”
commented Prof. Charalampos Tzoulis, Professor of Neurology and
Neurogenetics, Director of the K.G Jebsen Center for Translational
Research in Parkinson’s disease, and Co-Director of the
Neuro-SysMed Research Center, University of Bergen and Haukeland
University Hospital, Bergen, Norway. “Abnormal energy metabolism
due to dysfunction in the mitochondria has been linked to PD and is
believed to play a role in the initiation and progression of the
disease. Our previous findings have nominated NR as a potential
disease-modifying therapy for PD, which will not only target and
rectify disease-specific processes, but may also optimize neuronal
metabolism and fortify neurons, rendering them more resilient
against age-related stress and neurodegeneration. However, to
harness the full therapeutic potential of NR, we need to explore
higher dose regimens. This study establishes the short-term safety
of 3,000 mg NR daily and allows the clinical community to explore
high-dose options in future therapeutic trials. As for conclusive
proof on the therapeutic potential of NR in PD, we look forward to
the results from our year-long NO-PARK phase II/III study on 400
persons with PD, which is already ongoing at our Center, and
estimated to conclude by the end of 2024.” Public information on
the NO-PARK study can be viewed at neuro-sysmed.no and at
www.clinicaltrials.gov. Notably, all of Prof. Tzoulis’ clinical
research is academically-driven and based largely on public
funding.
About the study
Dr. Tzoulis and his team of researchers sought to assess
short-term tolerability and impact on NAD+ as well as clinical
severity of PD. Exploratory outcomes included changes in serum
homocysteine levels, fasting blood glucose, and serum insulin
levels.
The study was a randomized, double-blind, placebo-controlled,
phase I clinical trial in 20 individuals with idiopathic PD
fulfilling the criteria set by the Movement Disorders Society
(MDS). Individuals with PD were given 3,000 mg of NR per day or
placebo for four consecutive weeks. They were assessed based on
clinical and molecular measures, an electrocardiogram, and through
the MDS-UPDRS rating scale, a tool used by medical professionals
and researchers to assess and measure the severity of PD
symptoms.
Study highlights
- High-dose NR was safe and well-tolerated with no related
adverse events.
- NR significantly increased NAD+ levels and modified the NAD+
metabolome in whole blood.
- High-dose NR did not alter whole blood homocysteine, or other
major methyl donor groups, suggesting no impact on methyl donor
group pool.
- NR was associated with a significant improvement of clinical
symptoms of PD, measured by MDS-UPDRS, suggesting augmenting NAD+
levels may have a symptomatic anti-Parkinson's effect.
Relevance
This promising milestone research demonstrates that high-dose NR
at 3,000 mg per day is safe, well-tolerated, and may improve
clinical symptoms for PD. These results set the stage for the
long-term NO-PARK Phase II/III clinical study, which will determine
if NR can delay disease progression in persons with PD. Further,
Prof. Tzoulis and his team of investigators are conducting the
N-DOSE clinical trial to determine the optimal safe dose to assess
the efficacy of NR as part of the treatment of PD
(clinicaltrials.gov).
For additional information on the science supporting Niagen®
visit www.chromadex.com.
About ChromaDex:
ChromaDex Corp. is a global bioscience company dedicated to
healthy aging. The ChromaDex team, which includes world-renowned
scientists, is pioneering research on nicotinamide adenine
dinucleotide (NAD+), levels of which decline with age. ChromaDex is
the innovator behind NAD+ precursor nicotinamide riboside (NR),
commercialized as the flagship ingredient Niagen®. Nicotinamide
riboside and other NAD+ precursors are protected by ChromaDex’s
patent portfolio. ChromaDex maintains a website at
www.chromadex.com to which ChromaDex regularly posts copies of its
press releases as well as additional and financial information
about the Company.
Forward-Looking Statements:
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities and Exchange Act of 1934, as
amended, including statements related to whether the study revealed
groundbreaking insights into the potential of Niagen NR ingredient
as a therapy for Parkinson's disease and whether this research not
only demonstrates the safety and tolerability of high-dose Niagen
NR but also highlights its ability to significantly increase NAD+
levels and improve the clinical severity of PD. Statements that are
not a description of historical facts constitute forward-looking
statements and may often, but not always, be identified by the use
of such words as "expects," "anticipates," "intends," "estimates,"
"plans," "potential," "possible," "probable," "believes," "seeks,"
"may," "will," "should," "could" or the negative of such terms or
other similar expressions. Risks that contribute to the uncertain
nature of these forward-looking statements include the impact of
the COVID-19 pandemic on our business and the global economy; our
history of operating losses and need to obtain additional
financing; the growth and profitability of our product sales; our
ability to maintain sales, marketing and distribution capabilities;
changing consumer perceptions of our products; our reliance on a
single or limited number of third-party suppliers; and the risks
and uncertainties associated with our business and financial
condition. More detailed information about ChromaDex and the risk
factors that may affect the realization of forward-looking
statements is set forth in ChromaDex's Annual Report on Form 10-K
for the fiscal year ended December 31, 2022, ChromaDex's Quarterly
Reports on Form 10-Q and other filings submitted by ChromaDex to
the SEC, copies of which may be obtained from the SEC's website at
www.sec.gov. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof, and actual results may differ materially from those
suggested by these forward-looking statements. All forward-looking
statements are qualified in their entirety by this cautionary
statement and ChromaDex undertakes no obligation to revise or
update this release to reflect events or circumstances after the
date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20231130509791/en/
ChromaDex Media Contact: Kendall Knysch, Head of Public
Relations & Partnerships 310-388-6706 ext. 689
kendall.knysch@chromadex.com
ChromaDex Investor Relations Contact: +1 (949) 356-1620
InvestorRelations@ChromaDex.com
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