Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment. In accordance with the trial protocol pre-specified analysis of the endpoints, data from the two patient groups treated with Hylenex formulations (treatment groups) were pooled in comparison to a group consisting of patients using standard CSII with rapid acting analog insulin alone (control group). Adverse events were similar across the treatment and control groups. The most common treatment related adverse event in the Hylenex groups was mild infusion site discomfort.
With respect to secondary endpoints, the rate of overall hypoglycemic events (serum glucose of ≤70mg/dL) in the combined treatment groups was reduced by 12%>
"The reduction in hypoglycemia rates observed in this study is encouraging," stated Dr. Bruce Bode, Clinical Associate Professor, Department of Medicine, Emory University and the lead investigator for the trial. "Reduction of hypoglycemia risk remains one of the key unmet medical needs in the treatment of type 1 diabetes."
"The data from CONSISTENT 1 will be part of the data package that we will use to seek an update to the Hylenex label with the FDA to include key efficacy and safety data prior to our commencement of promotion for this use," stated Dr. Helen Torley, President and Chief Executive Officer. "We have initiated a dialogue with the FDA to understand the overall data package that will be required and the path to a label update."