Cebix is focused on the development of chronic replacement therapy based on human proinsulin C-peptide for the treatment of type 1 diabetic neuropathy.  The role of C-peptide will also be explored in type 1 diabetic nephropathy and retinopathy. 

Type 1 diabetes is characterized by the body's inability to produce proinsulin and consequently both insulin and C-peptide. We have identified C-peptide as a biologically active endogenous peptide hormone; it was originally considered to be only an inactive byproduct of insulin production. Based on extensive scientific data, we think that C-peptide deficiency in type 1 (insulin-dependent) diabetes patients is a contributing cause of many of the complications associated with long-term disease despite controlled insulin replacement therapy. It is estimated that 4 million people in North America and Europe have type 1 diabetes and about 80,000 Americans are diagnosed with type 1 diabetes every year. On a global scale, type 1 diabetes affects more than 8 million people and the incidence is rising.

Type 1 diabetes can over time lead to microvascular disease, which is damage to the small blood vessels. The primary microvascular complications associated with type 1 diabetes are:

• Neuropathy; resulting in reduced sensibility of the feet and lower legs, ulcer formation, gastrointestinal and sexual dysfunction, occurring in approximately 80% of type 1 patients after 15-20 years;

• Nephropathy; resulting in gradual loss of kidney function and eventually end-stage renal disease, occurring in up to 25% of type 1 patients after 15-20 years

• Retinopathy; resulting in retinal edema, hemorrhage, and loss of vision, occurring in 30-50% of type 1 patients after 15-20 years.

There are currently few treatment options for these complications of type 1 diabetes; specifically for diabetic neuropathy, there are no approved drugs to treat the microvascular damage. Therefore, if demonstrated to be effective and safe, C-peptide replacement therapy would represent a first-in-class treatment option for patients debilitated by diabetic neuropathy and other long-term complications of type 1 diabetes.