Newly Published Phase II Clinical Study Demonstrates that Supplementation with Niagen®, Patented Nicotinamide Riboside (NR), Elevates NAD+ Up to Fourfold, Improving Motor Coordination and Eye Movement in Ataxia Telangiectasia (AT) Patients
15 November 2023 - 2:32PM
Business Wire
This is the longest Niagen NR clinical trial to
date spanning two years and showcases that long-term Niagen NR is
safe and well tolerated
ChromaDex Corp. (NASDAQ:CDXC), one of the global authorities on
Nicotinamide Adenine Dinucleotide (NAD+) and healthy aging
research, shares results from a phase II clinical study published
in the peer-reviewed journal, Movement Disorders, by a team
of researchers led by Dr. Hilde Nilsen, University of Oslo,
Arkershus University Hospital, Norway. The clinical trial was part
of the ChromaDex External Research Program (CERP™), which donated
ChromaDex’s patented nicotinamide riboside (NR) ingredient,
Niagen®, one of the most efficient and superior NAD+ precursors
available, for the advancement of this research. The promising
results demonstrate that long-term supplementation with Niagen NR
effectively increased whole blood NAD+ levels up to fourfold,
improved coordination, and enhanced eye movement while maintaining
biomarkers of stable liver and kidney function in Ataxia
Telangiectasia (AT) patients. AT is a rare, inherited
neurodegenerative disorder characterized by premature aging,
cerebellar degeneration, immunodeficiency, and cancer
predisposition.
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Newly published phase II clinical study
demonstrates that supplementation with Niagen, patented
nicotinamide riboside (NR), elevates NAD+ up to fourfold, improving
motor coordination and eye movement in Ataxia Telangiectasia (AT)
patients (Graphic: Business Wire)
Building on a growing body of research, this is the second
published study (Veenhuis et al. in 2021) analyzing the therapeutic
effects of Niagen NR supplementation in AT patients and marks a
milestone as it is the longest Niagen NR clinical trial to date,
spanning two years, with results showcasing that long-term
supplementation is safe and well tolerated.
"NR supplementation has shown promising potential in supporting
brain health and cognition,” said Dr. Andrew Shao the Vice
President of Scientific & Regulatory Affairs at ChromaDex.
“Independent research through CERP suggests that NR may play a role
in maintaining neuronal function and promoting cognitive well-being
by supporting NAD+ levels in brain cells."
Individuals diagnosed with AT frequently experience profound
challenges in motor function, characterized by neurodegenerative
conditions like cerebellar ataxia, resulting in impaired movement
and coordination and they may exhibit oculomotor apraxia,
difficulties controlling eye movements. These factors often result
in a loss of independent walking ability, typically necessitating
the use of a wheelchair by the age of ten.
Dr. Nilsen remarks, “While the exact mechanisms underlying
cerebellar degeneration and neurodegeneration in AT are not fully
understood, research indicates inability to repair and respond
appropriately to DNA damage. AT research has shown that DNA damage
depletes NAD+, the crucial cellular coenzyme that plays an
essential role in mitochondrial function, DNA repair and cellular
energy production. This growing body of research is promising as it
demonstrates that NR supplementation may be a potential therapeutic
strategy for AT patients.”
About the study
This two year phase II clinical study was a single-arm
open-label intervention trial investigating the safety and efficacy
of long-term NR supplementation in 10 patients with AT (6 were
female, 4 were male, of which 7 were children, 3 were adults),
between the ages of 3 to 27 years. The patients were given oral NR
as an intervention starting with an initial dose of 150 mg/day,
gradually increasing to 300 mg/day, and reaching a final dose of
500 mg/day.
Study highlights
- NR supplementation was well tolerated, with no serious adverse
events.
- NR supplementation increased whole blood NAD+ levels up to
fourfold.
- Serum levels of AFP, serum alpha-fetoprotein and Nfl,
neurofilament light chain, biomarkers of AT progression, remained
stable for most participants over two years of NR supplementation,
suggesting that NR may slow or delay progression of AT.
- Long-term NR supplementation reduced ataxia symptoms and
improved motor coordination, eye movements, and overall
neurological functioning:
- Positive correlations were observed between NR supplementation
and improved AT Neurological Examination Toolkit (NEST) total
score, eye movements, SARA coordination scores, ICARS coordination
scores, and oculomotor scores.
- Biomarkers related to liver and kidney function did not show
clinically significant changes during the two-year treatment
period, indicating the NR supplementation was safe.
- Long-term blood glucose regulation, measured as HbA1c level,
remained stable in all participants.
- NR supplementation did not cause changes in hematological or
immunological parameters.
Relevance
Reaching a milestone in NR clinical research as the longest
published clinical study to date, results of this study demonstrate
that NR effectively increased whole blood NAD+ levels up to
fourfold, improved coordination, and enhanced eye movement in both
adults and children with AT, while maintaining biomarkers of stable
liver and kidney function. The outcomes of this study strongly
support the inclusion of NR supplementation as a standard clinical
approach for AT, however more research needs to be conducted to
confirm the impact of NR on motor skills such as standing and
walking.
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 results
demonstrate that long-term supplementation with Niagen NR
effectively increased whole blood NAD+ levels up to fourfold,
improved coordination, and enhanced eye movement while maintaining
biomarkers of stable liver and kidney function in Ataxia
Telangiectasia (AT) patients, whether the results showcase that
long-term supplementation is safe and well tolerated, whether NR
supplementation has shown promising potential in supporting brain
health and cognition, and whether this growing body of research is
promising or if it demonstrates that NR supplementation may be a
potential therapeutic strategy for AT patients. 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, 2021, 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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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
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