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news.Arisaph Pharmaceuticals has reported that the FDA has accepted the company's recently submitted investigational new drug application to evaluate ARI-2243 in a Phase I clinical trial for the treatment of type 2 diabetes.
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As part of the investigational new drug application (IND) submission, Arisaph has 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. Arisaph expects to initiate a first-in-man clinical trial during the first half of 2008.
Christopher Kiritsy, president and CEO of Arisaph, said: “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 our scientists have designed into the compound, yielding a clinically differentiated product in this market.”