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FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
Date:3/11/2008

our scientists have designed into the compound, yielding a clinically differentiated product in this market."

"This important regulatory milestone enables Arisaph to begin the process of demonstrating the compound's promise in the clinic," commented Alexander "Zan" Fleming, M.D., clinical/regulatory consultant to Arisaph, President and Chief Executive Officer of Kinexum and former head of diabetes review at FDA. "As an endocrinologist, the unprecedented preclinical efficacy of ARI-2243 is very intriguing and the potential benefits for patients are very exciting. I look forward to working with Arisaph to demonstrate the differentiated efficacy and safety of ARI-2243 in the clinic."

As part of the IND submission, Arisaph completed comprehensive nonclinical safety pharmacology and toxicology studies, including 28 day toxicology studies in rats and primates. The results show that ARI-2243 has a favorable safety pharmacology profile and has a high therapeutic index. Based on the preclinical efficacy of ARI-2243, the company believes that low doses will produce superior blood glucose lowering compared with other DPP-4 inhibitors.

Arisaph designed ARI-2243 as a once a day, orally active, smart DPP-4 inhibitor that is highly potent and functionally selective. In vitro, kinetic studies show that ARI-2243 has an extremely high affinity (Ki of 27 picomolar) for the DPP-4 enzyme and drug dissociation from the enzyme is very slow. Such kinetics confer potency and long activity. During OGTT in normal mice, ARI- 2243 was 250 times more potent than sitagliptin and maximally lowered blood glucose by 88%. Additionally, in ZDF rats, an animal model that develops overt diabetes, ARI-2243 significantly reduced hemoglobin A1c (HbA1c) by 2.5% versus no effect with vildagliptin.(3)

In addition to the compelling preclinical efficacy, ARI-2243 is functionally selective through a smart, "soft drug" inactivation process. Specifically, ARI-2243 binds rapidly and tig
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SOURCE Arisaph Pharmaceuticals, Inc.
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