Program Status

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 has launched an international 240-subject phase 2b trial in early 2013 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 diabetic patients.

Recent News

October 16, 2012
$30.9M Series B Investment closed and Joel Martin appointed as President and CEO
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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
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Cebix Incorporated ("Cebix") is a biopharmaceutical company focused on the treatment of diabetic complications including those affecting the function of nerves, kidneys, and eyes.  Cebix's candidate drug Ersatta™ is a long-acting form of C-peptide, a molecule (produced in conjunction with insulin) that is lacking in type 1 and some type 2 diabetic patients.  Cebix is initially developing Ersatta to combat the loss of nerve function and sensation in diabetic peripheral neuropathy.

 

C-peptide has been tested in 300 type 1 diabetic 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 in type 1 diabetes.  Cebix has developed a once-weekly form of C-peptide that has been tested in 72 type 1 diabetic 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.

 

An Introduction to C-Peptide from Cebix Inc on Vimeo.