Arisaph’s ARI-3037MO well tolerated in healthy male and female volunteers

"Niacin's efficacy across a broad range of lipid risk factors has long been recognized but flushing and increases in blood glucose have limited its use, particularly in high risk metabolic syndrome patients," commented Dr. Ernst Schaefer, Professor of Medicine, Tufts University School of Medicine. "The results from these two safety trials show that ARI-3037MO is devoid of such dose-limiting side effects, resulting in a significantly improved safety and tolerability profile compared with other niacin-based therapies."

In preclinical studies presented at the AHA in 2011, ARI-3037MO showed robust changes in lipids, including LDL-C, HDL-C and triglycerides. For example, once-daily treatments of ARI-3037MO lowered LDL-C in excess of 50% and lowered TGs by more than 70% compared with placebo in high-fat-fed hamster models. Additionally, non-clinical toxicology studies conducted in dogs and rats with ARI-3037MO showed that high exposure multiples could be achieved without serious adverse events, even at doses greater than 1000 mg per kilogram. The favorable preclinical safety and efficacy data reveal that ARI-3037MO has an extremely wide therapeutic index, indicating that ARI-3037MO will not be dose limited by adverse events. Consequently, it is expected that patients will be able to achieve improved efficacy observed with higher doses of niacin.  

SOURCE Arisaph Pharmaceuticals, Inc.