ChromaDex (CDXC) Completes pre-IND Meeting with U.S. FDA Over NR for Cockayne Syndrome; Offers Update
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ChromaDex Corp. (Nasdaq: CDXC) announced 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.”
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