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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

ose limited because of adverse side effects, such as gastrointestinal intolerance, liver enzyme elevations and flushing. The Company believes that ARI-3037MO can produce greater therapeutic benefits than existing forms of niacin as a result of mitigating such adverse side effects.  

In preclinical studies involving hamsters fed a high-fat diet, ARI-3037MO showed robust changes in lipids, including LDL and HDL cholesterols and triglycerides (TGs).  Specifically, once-daily treatments of ARI-3037MO lowered both LDL cholesterol and TGs greater than 70% from placebo.  In comparison, higher doses of niacin reduced LDL cholesterol and TGs approximately 50% from placebo.  Additionally, ARI-3037MO increased the proportion of HDL cholesterol to a greater extent than niacin.  ARI-3037MO treated hamsters showed a significant increase in ATP-binding cassette transporter A1 (ABCA1), apolipoprotein A-1 (ApoA1), and adiponectin compared to the vehicle control animals.  The ABCA1 and ApoAI increases are noteworthy, as the proteins that result from these transcripts are involved in the synthesis and maturation of HDL.  

"Significant lipid changes coupled with the increased mRNA levels for certain regulatory proteins involved in HDL synthesis and reverse cholesterol transport offers compelling evidence to support the mechanism based efficacy of this niacin analog," commented, Dr. Ernst Schaefer, Professor of Medicine, Tufts University School of Medicine. "The availability of an effective and tolerable niacin replacement would be a major advancement for the treatment of mixed lipid disorders."

In addition to the compelling preclinical efficacy, ARI-3037MO did not induce "flushing" as measured by changes in capillary blood flow via the ear in mice. Such capillary blood flow measurements have translated well in evaluating the effects of niacin on flushing in human clinical trials. Additionally, flushing was not observed during clin
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SOURCE Arisaph Pharmaceuticals, Inc.
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