About Us

Cebix is developing Ersatta^TM, a proprietary disease-modifying replacement peptide for the treatment of complications associated with diabetes. Ersatta is a long-acting form of C-peptide that, unlike other products simply directed at symptomatic relief, has the potential to reverse the chronic complications of diabetes. 

Type 1 and some type 2 diabetic patients have a C-peptide deficiency, which can cause a reduction in microvascular circulation, resulting in progressive damage to the nerves, retina and kidneys. This damage contributes to the onset of peripheral neuropathy, retinopathy and nephropathy, all chronic, long-term complications of diabetes. There are currently few treatment options for these complications of diabetes, and there are no approved drugs to treat the microvascular damage. 

Clinical data in more than 300 patients with type 1 diabetes demonstrates that C-peptide replacement therapy increases nerve blood flow and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. Ersatta exhibits the biological activity of the native peptide, restoring microvascular circulation, thereby improving function in the damaged areas. It has been shown that Ersatta improves nerve function in preclinical studies in a rat diabetic neuropathy model.

Cebix is evaluating Ersatta in a Phase 1b clinical trial in patients with type 1 diabetes. 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.