Cath Lab Digest

Data from Study of C-peptide Replacement Therapy in Patients with Type 1 Diabetes Presented at 72nd Annual Meeting of the American Diabetes Association.

Cebix Incorporated today announced that data from a Phase 1 study demonstrated that Ersatta™, the company's long-acting form of C-peptide, was well tolerated with no serious adverse events in patients with type 1 diabetes and exhibited a pharmacokinetic profile consistent with once-weekly dosing. The half-life of Ersatta was 6-7 days compared to one hour for the naturally occurring C-peptide. Ersatta is being developed as a disease-modifying treatment initially for diabetic peripheral neuropathy and eventually as a treatment for all microvascular complications associated with diabetes.

Results with Ersatta from the 30-patient randomized, blinded, placebo-controlled, multiple-ascending dose study with type 1 diabetic patients will be presented at the 72nd Annual Meeting of the American Diabetes Association on June 8-12, 2012 in Philadelphia. Preclinical data with Ersatta showing a dose-dependent improvement in nerve conduction velocity in rats with induced diabetic peripheral neuropathy, and the excellent safety profile from toxicology studies, will also be presented in a poster at the conference.

"There is a significant need for disease-modifying treatments for the long-term complications of diabetes such as peripheral neuropathy, since current treatments focus only on symptomatic relief," said Howard Foyt, MD, PhD, Chief Medical Officer at Cebix. "The preclinical data show that Ersatta improves nerve conduction velocity and consequently reverses the progression of peripheral neuropathy. The clinical study shows potential for safe, well-tolerated, weekly dosing, which will make this an attractive treatment option for diabetic patients currently on insulin therapy to aid in managing their complications."

Clinical studies in more than 300 patients with type 1 diabetes demonstrate that C-peptide replacement therapy increases nerve blood flow and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. Ersatta is a long-acting form of human C-peptide constructed through site-specific linkage to a single polyethylene glycol (PEG) moiety.

Dr. Foyt will present the clinical data in a poster entitled "Pharmacokinetics, Safety and Tolerability of a Long-Acting C-Peptide (Ersatta™) in Patients with Type 1 Diabetes" (Abstract 1078-P) at 11:30 am - 1:30 pm Eastern on Saturday, June 9. In a separate poster entitled "Nonclinical Efficacy and Safety of PEGylated C-Peptide" (Abstract 1107-P) also at 11:30 am - 1:30 pm Eastern on Saturday, June 9, preclinical data of Ersatta will be presented by Michelle Mazzoni, PhD, RAC, Vice President of Regulatory Affairs and Quality at Cebix. Both posters will be on display at the conference from 10:00 am on Saturday, June 9, until 3:00 pm on Tuesday, June 12, in the poster exhibit hall at the Pennsylvania Convention Center.

Based on the positive results in Phase 1, Ersatta is currently being evaluated in a Phase 2 clinical trial in 40 type 1 diabetes patients with mild to moderate diabetic peripheral neuropathy. Cebix has defined the pathway to marketing approval for Ersatta under U.S. Food and Drug Administration (FDA) subpart H accelerated approval regulations. Cebix has been granted Fast Track status by the FDA for Ersatta in the diabetic peripheral neuropathy indication.