ChromaDex Announces Top-line Results of its Second Human Clinical Trial
September 26 2017 - 6:30AM
- The Study Establishes an Effective Dose
Range and Validates Safety for NIAGEN® Nicotinamide Riboside
Chloride in 140 Humans Over an 8-week Period -
ChromaDex Corp. (NASDAQ:CDXC), an innovator of science-based,
proprietary health and wellness consumer products and ingredient
technologies that promote health longevity, announced today that
the initial results of its second human clinical study of NIAGEN®
nicotinamide riboside chloride (NR) have confirmed NR significantly
and sustainably raises the co-enzyme nicotinamide adenine
dinucleotide (NAD+) in 140 healthy human volunteers over 8-weeks.
In this study, participants in the active group received 100,
300, or 1000mg per day. Results from the randomized,
double-blind, placebo controlled, parallel-arm trial demonstrated
that NR produced statistically significant increases in blood NAD+
compared to placebo that were related to the dose of NR consumed,
demonstrating a dose response. Levels remained elevated
throughout the duration of the study, thereby establishing an
efficacious range for daily consumption. The study confirms
not only efficacy in raising NAD+, but also definitively documents
the safety of daily use of NR.
Frank Jaksch Jr., founder and CEO of ChromaDex, commented, "This
study is a pivotal milestone in the clinical science of NIAGEN® and
is key to better understanding its role in human health. For the
first time, we have established an effective dose range for long
term use in humans. This paves the way for important clinical work
in the modulation of aging, as well as in other health-related
categories.”
Maintenance of sufficient levels of NAD+ is key to cellular
energy metabolism and mitochondrial function. Cellular energy
not only fuels our most basic bodily functions, it is also
necessary to defend against oxidative stress in the body, repair
DNA damage, and create the building blocks for DNA and RNA.
In humans and animals, NAD+ levels decrease in normal aging.
This observation has led to dozens of published preclinical studies
demonstrating the efficacy of NIAGEN® in raising NAD+, as well as
some of the potential mechanisms by which NIAGEN® can help reduce
the metabolic stresses of normal aging.
Study publication in peer review literature will be critically
important for supporting future University and NIH-Sponsored
clinical efficacy trials. The full results of the study will
be submitted for publication in a peer review journal shortly.
For more information on ChromaDex, visit:
https://www.chromadex.com/.
About ChromaDex:ChromaDex
leverages its complementary business units to discover, acquire,
develop and commercialize patented and proprietary health and
wellness consumer products and ingredient technologies that promote
healthy longevity. In addition to our consumer product and
ingredient technologies units, we also have business units focused
on natural product fine chemicals (known as "phytochemicals"), and
product regulatory and safety consulting. As a result of our
relationships with leading universities and research institutions,
we are able to discover and license early stage, IP-backed
ingredient technologies. We then utilize our in-house chemistry,
regulatory and safety consulting business units to develop
commercially viable ingredients. Our consumer product and
ingredient portfolio are backed with clinical and scientific
research, as well as extensive IP protection. Our portfolio of
patented ingredient technologies includes NIAGEN® nicotinamide
riboside; pTeroPure® pterostilbene; PURENERGY®, a
caffeine-pTeroPure® co-crystal; IMMULINA™, a spirulina extract; and
AnthOrigin®, anthocyanins derived from a domestically-produced,
water-extracted purple corn husk. To learn more about ChromaDex,
please visit www.ChromaDex.com.
Forward-Looking Statements:This
release contains forward-looking statements relating to ChromaDex
and ChromaDex’s business 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 results of the NIAGEN® study and its
significance, the importance of maintaining sufficient levels of
NAD+ and it being the key to cellular energy metabolism and
mitochondrial function. 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. 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, 2016, 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.
ChromaDex Investor Relations Contact: Andrew
Johnson, Director of Investor Relations 949-419-0288
andrewj@chromadex.com
ChromaDex Public Relations Contact: Breah
Ostendorf, Director of Marketing 949-537-4103
breaho@chromadex.com
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