Program Status
Cebix is developing ErsattaTM, a proprietary disease-modifying replacement peptide for the treatment of complications associated with diabetes. Ersatta is a long-acting form of C-peptide that has the potential to reverse the chronic complications of diabetes, including progressive damage to the nerves, kidneys and retina. Cebix is currently evaluating Ersatta in a Phase 1b clinical trial in type 1 diabetics. Cebix has defined the pathway to marketing approval for Ersatta™ under U.S. Food and Drug Administration (FDA) Subpart H. Nerve conduction velocity will be the sole primary endpoint for a Phase 2/3 pivotal trial in diabetic peripheral neuropathy, which Cebix plans to initiate in the first half of 2012. Cebix has been granted fast track status by FDA for Ersatta™ in the diabetic peripheral neuropathy indication. While Ersatta is initially being developed for this indication, the drug has potential in autonomic neuropathy, retinopathy, nephropathy and erectile dysfunction, all long-term complications seen in both type 1 and type 2 diabetic patients.
Cebix Incorporated (“Cebix”) is a biopharmaceutical company focused on the development of chronic replacement therapy based on human proinsulin C-peptide for the treatment of type 1 diabetic neuropathy.
Cebix has, over the past 15 years, generated preclinical and clinical data establishing C-peptide as a potent therapeutic in the treatment and prevention of long-term complications of type 1 diabetes. Specifically, the Company has executed eleven clinical trials in diabetic neuropathy and nephropathy and treated approximately 300 patients with type 1 diabetes. These data suggest that C-peptide is a promising novel intervention in the progression of late stage complication in type 1 diabetes. The Company has recently developed a once weekly dosage form which it is currently advancing into clinical trials. Cebix has met with the FDA and reached agreement with the Agency on our development plans in diabetic neuropathy. The benefit of C-peptide replacement therapy will also be explored in diabetic nephropathy and retinopathy.
