Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced additional Phase 2 results that demonstrated faster insulin absorption and increased peak insulin concentrations in type 1 diabetic patients after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with Humulin® R (regular human insulin), a mealtime insulin. In addition, study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal and less hypoglycemia compared to Humulin R alone. These results provide additional confirmation in type 1 diabetes patients of the effects observed in a Phase 1 study conducted in healthy volunteers. The company presented these results today at the European Association for the Study of Diabetes in Vienna.
“This study has demonstrated faster insulin absorption and a shorter blood insulin concentration profile for both combinations of lispro and regular insulin plus PH20 compared to either insulin alone in type 1 diabetic patients. The PK shift results in lower hyperglycemia after a meal,” stated Doug Muchmore, M.D., vice president, endocrinology clinical development. The results from the study for Humalog® (insulin lispro) with and without PH20 were previously presented at the American Diabetes Association meeting in June 2009.
The goal of Halozyme’s ultrafast insulin program 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. Halozyme is 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, Halozyme seeks 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, and registration trial-enabling treatment studies are ongoing or planned, that will investigate the various attributes of Halozyme’s insulin product candidates. A multidose crossover treatment study in type 1 patients is currently underway that compares regular insulin with PH20 to Humalog, where patients self-administer each test drug for three months. Results are expected in 3Q10.
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