Halozyme Says Consistent 1 Trial Of Hylenex Recombinant Met Primary Endpoint

(RTTNews) - Halozyme Therapeutics, Inc. (HALO) reported that the primary endpoint of non-inferiority of A1C levels at six months was achieved for the CONSISTENT 1 trial. The study evaluates Hylenex recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration or 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 with no pre-treatment.

As per the trial protocol pre-specified analysis of the endpoints, data from the two patient groups treated with Hylenex formulations were pooled in comparison with a group consisting of patients using standard CSII with rapid acting analog insulin alone. The adverse events were similar across the treatment and control groups, while the most common treatment related adverse event in the Hylenex groups was mild infusion site discomfort.

In relation with the secondary endpoints, the rate of overall hypoglycemic events in the combined treatment groups was reduced by 12%, compared with the control group. Further, the rate of hypoglycemic events where serum glucose was<56mg/dL was reduced by 23% in the combined treatment groups compared with the control group.

Helen Torley, President and Chief Executive stated, "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." The company has initiated a dialogue with the FDA to understand the overall data package that would be required and the path to a label update.