Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced dose response study results that demonstrated faster insulin absorption and increased peak insulin concentrations after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with regular human insulin and with insulin lispro. The enhanced absorption effects were observed at clinically relevant insulin doses across a broad range of PH20 concentrations. In addition, study results also showed accelerated insulin action as measured by glucose infusion rates in this euglycemic glucose clamp study. The company presented these results today at the International Diabetes Federation Congress in Montreal.
“This study has demonstrated faster insulin absorption for varying insulin doses and PH20 concentrations. Even at relatively low insulin doses and low concentrations of PH20, the faster insulin absorption produced an acceleration of the effects of insulin,” said Doug Muchmore, M.D., vice president, endocrinology clinical development. “This dose response study allowed us to determine the optimal enzyme concentration, an important milestone in the development of our ultrafast insulin program, which has already been useful in the design of ongoing clinical trials.”
The study enrolled healthy volunteers in cohorts of four subjects who received either 3U or 12U of regular insulin or 1.5U or 6U of insulin lispro, without PH20 and with five different concentrations of PH20 during a total of six clamp procedures. The results demonstrated that PH20 is a potent enhancer of insulin absorption over a wide range of concentrations, 0.3 to 80 micrograms per mL, with an optimum effect at about 5 micrograms per mL. Observed adverse events were generally mild, and PH20 was well tolerated when co-injected with either regular human insulin or insulin lispro.
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® (insulin lispro), where patients self-administer each test drug for three months. Results are expected in 3Q10.
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