IRVINE, Calif., Nov. 11, 2016 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions to dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today that it has completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) on Nov. 1, 2016. During the meeting, ChromaDex and the FDA discussed the development plan for nicotinamide riboside (NR) for Cockayne Syndrome, which is a rare pediatric orphan disease that results in a significantly shortened lifespan in affected children.
The FDA addressed ChromaDex’s questions related to preclinical/clinical data and planned clinical trial design. The FDA also provided greater clarity on the requirements needed to file an IND to initiate a Phase I/II clinical trial in patients with Cockayne Syndrome. ChromaDex anticipates filing this IND in Q1 2017. The FDA has indicated it will consider a Fast Track designation for nicotinamide riboside at the time of the IND submission.
“We are encouraged by the productive discussions with the FDA,” said Dr. Claire Kruger, ChromaDex’s sr. director of regulatory. “We believe that preclinical/clinical data supports the clinical advancement of nicotinamide riboside and we are currently undertaking IND-enabling next steps.”
In 2014, the results of a mouse study performed in collaboration with ChromaDex by the National Institute on Aging (NIA), a member of the National Institutes of Health (NIH), were published in Cell Metabolism in November 2014. The results indicated that NR was effective at restoring NAD+ levels in mitochondria and rescuing phenotypes associated with a devastating accelerated aging disease known as Cockayne Syndrome (CS).
CS is a rare genetic disorder that causes neurodegeneration, severe sensitivity to sunlight, and failure to gain weight and grow at a normal rate. CS patients share the same neurodegenerative traits that are seen in many mitochondrial disorders and diseases associated with aging. Mitochondrial maintenance may be central in the aging process, and interventions that preserve mitochondrial function appear to extend the lifespan of model organisms.
Frank Jaksch, CEO and Founder of ChromaDex stated, “Submitting this IND will be a significant milestone ChromaDex’s drug development strategy for NR and other NAD+ precursors in our pipeline. Cockayne Syndrome is part of the overall drug development strategy that addresses NAD+ precursors for numerous orphan diseases associated with mitochondrial dysfunction. NAD+ is an upcoming, attractive target for drug discovery, and we believe ChromaDex is well positioned to capitalize on this field as it develops.”
About ChromaDex:
ChromaDex leverages its complementary business units to discover, acquire, develop and commercialize patented and proprietary ingredient technologies that address the dietary supplement, food, beverage, skin care and pharmaceutical markets. In addition to our ingredient technologies unit, we also have business units focused on natural product fine chemicals (known as "phytochemicals"), chemistry and analytical testing services, and product regulatory and safety consulting (known as Spherix 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 ingredient portfolio is 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 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 NR research, outcome of clinical trials, and FDA statements and approvals. 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 January 2, 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.