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Cebix starts Phase 1b Ersatta trial

PBR Staff Writer Published 17 June 2011

Cebix has started a Phase 1b study to assess the safety, tolerability, single and multiple dose pharmacokinetics of Ersatta, a proprietary, mono-pegylated version of C-peptide, in patients with type 1 diabetes.

Cebix will recruit around 30-60 patients in the trial.

Earlier, in preclinical trials, Ersatta has demonstrated improved nerve function in a rat diabetic neuropathy model.

The company intends to commence Phase 2/3 pivotal trial in diabetic peripheral neuropathy in the first half of 2012.

Cebix chief scientific officer John Wahren said they have successfully created a long-acting form of C-peptide to improve the drug profile for patients and physicians and have initiated their first clinical trial with Ersatta in patients with type 1 diabetes.