Key Developments For Halozyme Therapeutics, Inc.
Halozyme Therapeutics, Inc. (HALO.O) (Consolidated Issue listed on NASDAQ Global Market)
Halozyme Therapeutics, Inc. Study Results Show Faster Insulin Absorption When Administered In Combination With Wide Range Of PH20 Enzyme Concentrations
Halozyme Therapeutics, Inc. 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 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.
Halozyme Therapeutics, Inc. Presents Phase 2 Results For Regular Insulin-PH20 Confirming Faster Insulin Absorption And Superior Glucose Control
Halozyme Therapeutics, Inc. 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. 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.
Halozyme Therapeutics, Inc. Begins Clinical Trial To Compare Three Insulin Analogs And Provides Update on Ultrafast Insulin Program
Halozyme Therapeutics, Inc. announced the commencement of a Phase 1 clinical study that will assess the effects of three approved prandial (mealtime) insulin analogs administered with its 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 the Company 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. The Company also announced an update on Ultrafast Insulin Program. It 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). . A number of Phase 1 and Phase 2 clinical pharmacology trials investigating the various attributes of the Company's insulin product candidates are currently underway.
Halozyme Therapeutics, Inc. Announces Initiation of Phase 1 Clinical Trial With Roche Biologic
Halozyme Therapeutics, Inc. announced that the first patient was dosed in a Phase 1 pharmacokinetic clinical trial using Enhanze Technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation of a Roche biologic. This biologic represents the third Roche compound directed to an exclusive target to enter the clinic as part of the Halozyme Roche collaboration. Initiation of the clinical trial has triggered a payment under the agreement.
Halozyme Therapeutics, Inc. Begins Phase II Clinical Trial Of Insulin-PH20 In Type II Diabetic Patients
Halozyme Therapeutics, Inc. announced the commencement of patient dosing in a Phase II clinical study of Insulin-PH20 in patients with Type II Diabetes Mellitus. This randomized cross-over design study is designed to compare the postprandial glycemic excursions following a standardized test meal after treatment with either insulin lispro+PH20 or regular insulin+PH20 relative to treatment with lispro (Humalog) alone. This Phase II study will investigate the pharmacokinetics (PK) and glucodynamics of insulin lispro+PH20 and regular insulin+PH20 versus lispro alone. The primary endpoint of this study is the glycemic excursion over the first four hours. Secondary endpoints include the comparison of optimum doses of insulin required for glycemic control, as well as various PK, PD and safety endpoints. A number of clinical trials investigating Halozyme`s Insulin-PH20 are currently underway and more trials are planned.
