Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced the commencement of a Phase 1 clinical study that will assess the effects of three approved prandial (mealtime) insulin analogs administered with its proprietary rHuPH20 (PH20) hyaluronidase enzyme compared to each of the analogs alone. This randomized, three-way cross-over design, euglycemic clamp study will compare the postprandial pharmacokinetics (PK) and glucodynamics (GD) of the insulin analogs. Previous studies conducted by Halozyme have demonstrated that the combination of insulin lispro (Humalog®) with PH20 yielded faster systemic insulin absorption, increased peak insulin concentrations, and improved glycemic control that better mimicked the normal metabolic response to physiologic insulin release when compared to insulin lispro alone.
“This clinical study is designed to investigate and compare the pharmacokinetic and glucodynamic effects of our PH20 enzyme administered with each of the three commercially available insulin analogs,” stated Doug Muchmore, M.D., Halozyme’s vice president of clinical development for endocrinology. “To our knowledge, this is the first study that will compare all three analogs in a head-to-head study of this type. It will broaden our experience with additional analogs and provide insight regarding how our enzyme may influence their effects.” Additional information about this study can be found at clinicaltrials.gov using the identifier NCT00979875. Results of this study should be available by 2Q10.
Update on Halozyme’s Ultrafast Insulin Program
Halozyme’s goal is to develop a best-in-class insulin product in comparison to the current standard of care analog products that participate in the growing $3 billion prandial insulin market. We are developing two different products in parallel to explore a maximum range of value creating opportunities: recombinant human insulin formulated with PH20 (Insulin-PH20), and a rapid acting insulin analog formulated with PH20 (Analog-PH20). With a more rapidly absorbed, faster acting insulin product, we seek to demonstrate one or more significant improvements relative to existing treatment, such as improved glycemic control, less hypoglycemia, and less weight gain. A number of Phase 1 and Phase 2 clinical pharmacology trials investigating the various attributes of Halozyme’s insulin product candidates are currently underway.