Results Announced for New Formulation of Hylenex

Halozyme Therapeutics announced results from CONSISTENT 1, a trial evaluating the use of Hylenex recombinant (hyaluronidase human injection) and a new formulation of Hylenex when used as pretreatment at the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion in comparison to no pre-treatment, at the 2014 American Diabetes Association Scientific Sessions.

The CONSISTENT 1 (CONtinuous Subcutaneous Insulin infusion STudy ENrolling Type 1 Diabetes) trial is evaluating the safety and efficacy of Hylenex recombinant and a new formulation of Hylenex under FDA review in a six-month trial with an 18-month extension phase in 455 patients with type 1 diabetes. The primary efficacy endpoint is a comparison of the change from baseline in A1C levels at six months.

Results demonstrated that the study’s primary endpoint of non-inferiority for A1C at six months between the use of Hylenex and the new formulation of Hylenex in comparison to no pre-treatment was met. In addition to other trial data, the poster also presented data indicating that there was a potential reduction in the rate of hypoglycemic events associated with the use of the Hylenex formulations in comparison to no pre-treatment.

Hylenex recombinant is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, to facilitate subcutaneous fluid administration and in subcutaneous urography.

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