Cebix is developing Ersatta™, 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 reduce the chronic complications of diabetes, including progressive damage to the nerves, kidneys, and retina. Cebix has been granted fast track status by FDA for Ersatta for treating diabetic peripheral neuropathy. Cebix recently completed a 72-subject phase 1/2 clinical trial evaluating Ersatta in patients with type 1 diabetes. The trial validated Ersatta’s benign safety profile and once-weekly administration, and provided favorable initial results in improved nerve conduction velocity (a measure of peripheral neuropathy). Cebix is currently conducting an international 240-subject phase 2b trial measuring nerve conduction velocity as the primary endpoint. While Ersatta is initially being developed for peripheral neuropathy, the drug has potential in autonomic neuropathy, retinopathy, nephropathy, and erectile dysfunction, all long-term complications seen in both type 1 and type 2 diabetes patients.
October 16, 2012
$30.9M Series B Investment closed and Joel Martin appointed as President and CEO
September 07, 2011
Cebix to Chair Symposium on C-Peptide and the Pathophysiology of Diabetes at European Association for the Study of Diabetes Annual Meeting 2011
C-peptide (native form, no modifications) has been tested in 300 type 1 diabetes patients in nineteen clinical trials to study its effects in diabetic complications including neuropathy and nephropathy. Data from these trials suggest that C-peptide is a promising novel intervention in the progression of complications experienced in type 1 diabetes. Cebix has developed a once-weekly form of C-peptide that has been tested in 72 type 1 diabetes patients in a phase 1/2 trial. Cebix is now advancing Ersatta through phase 2 clinical testing for neuropathy with secondary measures in nephropathy. Further information on Cebix's clinical trials may be found at: www.clinicaltrials.gov.