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news.Reduction in intrasubject absorption variability for the combination of lispro, analog insulin, plus PH20 (hyaluronidase) compared to subcutaneous injection of lispro alone.
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Halozyme has reported the insulin variability study results that demonstrate reduced intrasubject absorption variability for the combination of lispro, plus PH20 (hyaluronidase) compared to subcutaneous injection of lispro alone. When compared to lispro alone, the combination of lispro with PH20 reduced the variability for early and late insulin absorption.
The study results confirmed previously reported acceleration for both insulin absorption and action by coadministration of PH20.
Doug Muchmore, vice president at endocrinology clinical development, said: “Reduced variability for the combination of lispro with PH20 across a number of key pharmacokinetic measures, especially during the first two hours after administration, is an exciting clinical result. For diabetes patients this could mean more consistent and predictable insulin effects for meal time insulin injections.”
The study enrolled 22 healthy subjects who received two doses of three different treatments: insulin lispro alone, regular insulin with PH20, and insulin lispro with PH20 in a euglycemic glucose clamp trial design. All subjects underwent six clamp procedures. The study demonstrated that timing and degree of insulin absorption between doses administered to the same subjects on different occasions were more consistent when combined with PH20 than for either insulin administered alone.
Halozyme presented additional new data confirming that PH20 at the optimised dose of 5µg/100 U of insulin accelerated the absorption and action of insulin. Furthermore, PH20 improved the PK dose proportionality responses to prandial insulins across a range of physiologically relevant doses, including 2 to 20 U for insulin lispro and 6 to 24 U for human insulin.
The primary 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).