Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced Phase 2 results demonstrating that Insulin-PH20 (recombinant human insulin with rHuPH20) produced glycemic control comparable to lispro, a widely prescribed prandial (mealtime) insulin analog.
The overall safety and adverse event profiles for the two agents were comparable and both treatments were well tolerated. Insulin-PH20 achieved the primary endpoint of non-inferiority for glycemic excursions relative to lispro alone in this study conducted in a take-home diabetes treatment setting.
This study represents the first reported experience in a clinical trial where patients received Halozyme’s recombinant human hyaluronidase enzyme, rHuPH20, three times daily for 12 weeks for a total of over 10,000 doses of enzyme with insulin. Halozyme presented these results today at the Diabetes Technology Society meeting in Bethesda, Md.
“Halozyme has demonstrated that the combination of its PH20 enzyme with recombinant human insulin accelerates the pharmacokinetic profile to that of the currently marketed prandial analogs.
The combination produces treatment effects and a safety profile comparable to the analog insulin lispro,” stated Doug Muchmore, M.D., vice president of endocrinology clinical development.
“The glycemic excursion results, occurrence of hypoglycemia, and reported adverse events were comparable for the two test treatments.
We look forward to the results of ongoing Phase 2 studies that we anticipate will demonstrate the superiority of analog insulin with PH20 compared to analog insulin alone.
” The goal of Halozyme’s Ultrafast Insulin program is to develop a mealtime insulin for patients with type 1 or type 2 diabetes that allows patients to better manage their blood glucose levels and safely reach treatment goals without excessive hypoglycemia.
“The increasing use of continuous glucose monitoring has revealed a vital unmet need for a faster acting prandial insulin to improve post-prandial glucose control,” stated Satish K. Garg, M.D., Professor of Medicine and Pediatrics at the Adult Clinic of the Barbara Davis Center for Diabetes of the University of Colorado Denver, School of Medicine, and an investigator in this Phase 2 clinical trial. “The PH20 technology effectively enhanced the action of recombinant human insulin in this study.
If the ongoing Phase 2 studies with the analog insulin plus PH20 combination show an even faster onset of action profile, this could significantly improve diabetes management.”
Source: Halozyme Therapeutics, Inc