Our endocrinology development activity focuses on insulin, a mainstay of treatment for people with diabetes. This program combines our PH20 hyaluronidase enzyme with insulin, a frequently prescribed, commercially successful pharmaceutical already approved and on the market. The primary goal of our Ultrafast Insulin program is to develop a best-in-class prandial insulin in comparison to the current leading analogs on the market.
Ultrafast Insulin – Making Mealtime Insulin Better
Our clinical studies continue to demonstrate that the combination of currently available insulin products with our PH20 enzyme results in more rapidly absorbed and faster acting insulin with a shorter duration of effect and greater consistency from dose to dose. We believe that this faster, more reproducible action will address important unmet medical needs, such as better and more consistent glycemic control with less hypoglycemia and hyperglycemia, and less weight gain. These potential benefits would be significant but must first be demonstrated and proven in clinical development.
The results of a Phase 1 study conducted in healthy subjects, where we combined PH20 with Humulin® R (regular human insulin) and with Humalog® (insulin lispro), demonstrated significantly faster and higher insulin plasma concentrations compared to either insulin alone. Faster acting insulin could more closely mimic the release of natural insulin in the body and provide patient benefits such as reduced hypoglycemia, lower intra-subject variability, and less weight gain.
We presented the results from our first Phase 2 mealtime study in patients with type 1 diabetes in 2009. This study tested PH20 with regular insulin and with insulin lispro and compared the combinations to each insulin administered alone. The study confirmed our previous Phase 1 findings in healthy subjects that PH20 accelerated insulin absorption to yield a more rapid insulin concentration profile.
This more rapid pharmacokinetic profile led to improvements in the blood glucose response. The Phase 2 study demonstrated a significant reduction in both peak and total hyperglycemic excursion for the combination of lispro with PH20 and regular insulin with PH20 compared to either insulin alone. The accelerated PK profile associated with co-administration of PH20 can result in a clinically meaningful reduction in post meal glycemic excursion, an important component of diabetes management.
Later this year, we expect to present the results from three insulin studies within our Ultrafast Insulin program at major medical meetings. A brief description of each study can be found below.
The first is a Phase 2 treatment study in patients with type 1 diabetes that compares three times per day dosing for three of regular insulin with PH20 to insulin analog alone. The study will provide insight into the ability of PH20 to improve regular insulin compared to treatment with analog insulin and will provide important safety information with regard to chronic dosing for our PH20 enzyme. For additional information about this study please visit clinicaltrials.gov.
Our first study in type 2 diabetes patients, a standard meal study, compares insulin lispro plus PH20 and regular insulin plus PH20 to lispro alone. The primary endpoint of this trial is glycemic excursion over the first four hours following the meal challenge. This endpoint, as well as other pharmacokinetic and pharmacodynamic endpoints, will be compared at the optimum doses for each therapy. For additional information about this study please visit clinicaltrials.gov.
The third study compares the three approved prandial insulin analogs with and without PH20 in healthy subjects. It is a head to head comparison of all three analogs and will examine their absorption and action profiles with and without PH20. For additional information about this study please visit clinicaltrials.gov.
Our Ultrafast Insulin clinical development program is designed to provide information regarding key product attributes that we, as well as potential partners, would want to know. Later this year, we will have the results of seven clinical trials that we have conducted to demonstrate the value of our enzyme in combination with insulin. Two additional treatment studies in type 1 and type 2 diabetes patients that will compare analog insulin with and without PH20 are expected to be underway during the third quarter of 2010. These additional clinical studies should continue to generate data that builds value for the Ultrafast Insulin program.
