Halozyme Therapeutics, Inc. announced the initiation of two phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog, and insulin lispro, the active ingredient in Humalog. Diabetes patients enrolled in these cross-over design studies will receive an insulin analog alone and the Analog-PH20 treatment for 12 weeks each. Previous studies have demonstrated that the coinjection of rHuPH20 with an insulin analog results in a more physiologic fast-in, fast-out profile that enhances the mealtime glycemic control for each analog.
"These studies are designed to test whether the ultrafast profile of the Analog-PH20 insulin product will result in measurable benefits for patients with diabetes," stated Jonathan Lim, M.D., Halozyme's president and CEO. "We expect these studies will demonstrate that our rapid acting ultrafast insulin enables more patients to safely reach their A1C goal and to achieve better control of their blood glucose levels. Our partnership dialog is ongoing, and these studies will help support the clinical development and regulatory plans for a future partner."
These phase 2 clinical trials, one in type 1 diabetes patients and the other in type 2 patients, will compare two ultrafast insulin analog products formulated with rHuPH20 to an active comparator, Humalog (insulin lispro). Each study will enrol approximately 110 patients and begins with a 4 to 6 week titration period where patients optimize their basal insulin dosing. Patients will then be randomized to receive either the Lispro-PH20 or Aspart-PH20 investigational study drugs and the active comparator three times daily for 12 weeks each in a random sequence. The primary endpoint of each study will be a comparison of glycemic control, as assessed by the change in A1C from baseline. Data regarding postprandial glucose levels, the proportion of patients that safely achieve A1C targets, rates of hypoglycemia, weight change and additional endpoints will be collected.
The goal of Halozyme's Ultrafast Insulin program is to develop a best-in-class mealtime insulin product compared to the currently prescribed analogs that participate in the growing $3.8 billion worldwide prandial insulin market.
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets.