SmartInsulin Stability, Process Development, Assay Validation and GMP Manufacturi

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DESCRIPTION (provided by applicant): The Company is developing SmartInsulin(tm), which is intended to be a once-a-day, self- regulating insulin injection for the treatment of Type I diabetes. It is designed as a "drop- in" replacement product for the 4 million insulin-using diabetics in the United States. SmartInsulin is designed to provide significant benefits to insulin-dependent diabetics including fewer injections, less frequent blood sugar monitoring, reduced incidence of low blood sugar levels and single-dose control of both fasting and mealtime blood sugar levels. SmartInsulin is a nanostructured material that self-assembles from two biomolecular building blocks: a glycosylated insulin-polymer conjugate (IPC) and a multivalent glucose-binding molecule (GBM). The work covered in this submission is built on the successful results of a two-year NIH SBIR Phase 1 grant, an NIH SBIR Phase 2 grant, and preliminary results from a DOD grant regarding the safety and efficacy of SmartInsulin in large animal models. These results show that SmartInsulin has met its "proof-of-concept" technical goals, but IND- enabling studies must be conducted in order to bring SmartInsulin to the clinic. This requires very detailed and expensive GLP toxicity/ADME studies and a GMP manufacturing process before obtaining an IND from the Food and Drug Administration. This project is intended to provide a clear path to GMP-quality SmartInsulin by establishing formulation stability, supporting assay development, qualification and validation activities and allowing the sourcing of the raw materials to key suppliers. The impacts to public health as a result of this project are potentially significant. Poor glycemic control has been shown to cause a host of diabetic complications which result in over $54 billion annually in medical costs. The landmark Diabetes Control and Complications Trial (DCCT) and the UK Prospective Diabetes Study (UKPDS) have clinically proven that tighter glycemic control, as measured by lower glycosylated hemoglobin A1c (HbA1c) levels, significantly reduces the incidence of these complications. SmartInsulin is designed to provide tighter glycemic control, lowered HbA1c levels, and thus decreased incidence of diabetic complications. SmartCells is developing SmartInsulin(tm), which is intended to be a once-a-day, self- regulating insulin injection for the treatment of Type I diabetes. Poor control of blood sugar levels has been shown to cause many diabetic complications which result in over $54 billion annually in medical costs. SmartInsulin is designed to provide tighter control of blood sugar levels and thus decreased incidence of diabetic complications.