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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

-- ARI-2243 is a highly potent DPP-4 inhibitor being developed for the

treatment of Type II diabetes -- ARI-2243 produced a compelling 2.5% reduction in HbA1c in refractory

diabetic animal model

-- ARI-2243 is a first-in-class "soft drug" conferring functional

selectivity -- Nonclinical toxicology evaluation shows ARI-2243 has high therapeutic

index

BOSTON, March 11 /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-2243 in a phase I clinical trial in healthy volunteers. ARI-2243 is a highly potent DPP-4 inhibitor, possessing superior preclinical efficacy and a high therapeutic index established in nonclinical toxicology testing. In addition to significant potency for inhibiting the DPP-4 enzyme, ARI-2243 possesses a first-in-class "soft drug" feature by which the compound becomes inactive when unbound to the target enzyme, thereby contributing to improvements in safety. Arisaph expects to initiate a first-in-man clinical trial during the first half of 2008 and is developing the product for the treatment of Type II diabetes, which afflicts about 20 million people in the United States and in excess of 170 million people worldwide.(1,2)

"The FDA's acceptance of our IND marks an important milestone for the company," said Christopher P. Kiritsy, President and Chief Executive Officer of Arisaph Pharmaceuticals. "With ARI-2243, we are making progress towards our goal of developing best-in-class medicines for validated targets. We believe ARI-2243 has the potential to not only exhibit a superior efficacy profile but also show a favorable safety profile by means of the unique "soft drug" feature that
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SOURCE Arisaph Pharmaceuticals, Inc.
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