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FDA Accepts Investigational New Drug Application for ARI-3030MO; First in Man Clinical Trial to Begin During First Quarter of 2011
Date:3/21/2011

BOSTON, March 21, 2011 /PRNewswire/ -- Arisaph Pharmaceuticals, Inc., a privately held drug discovery biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's recently submitted Investigational New Drug (IND) application to evaluate ARI-3037MO in a phase I human clinical trial in healthy volunteers.  ARI-3037MO, a proprietary new chemical entity, is a once-daily, niacin analog being developed for the treatment of dyslipidemia. In preclinical pharmacology studies, the compound produced greater lipid responses than niacin in a relevant animal model of hyperlipidemia.  Additionally, ARI-3037MO showed an extremely favorable safety profile, including the absence of flushing, in non-clinical drug safety studies. The Company believes that an efficacious and well tolerated niacin analog will be more widely utilized than existing forms of niacin in treating hypercholesterolemia, a disorder that afflicts as many as 93 million Americans according to data published by the American Heart Association.(1)

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"The FDA's acceptance of our IND is a major milestone for Arisaph, particularly considering that we developed the compound from lead selection to IND filing in about 9 months," said Christopher P. Kiritsy, President and Chief Executive Officer of Arisaph Pharmaceuticals.  "With ARI-3037MO, we have designed a once a day, structural analog of niacin that retains niacin's beneficial biological effects on lipids without producing the irritating side effect of flushing."    

As part of the IND submission, Arisaph completed comprehensive nonclinical drug safety studies, including 28-day toxicology studies in rats and dogs.  The results show that ARI-3037MO has a favorable safety pharmacology profile and a wide therapeutic index.  One of the major challenges with current forms of niacin is that they are d
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SOURCE Arisaph Pharmaceuticals, Inc.
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