SAN DIEGO, June 28 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced clinical trial results showing that the addition of its proprietary rHuPH20 (recombinant human hyaluronidase, PH20) enzyme to three different mealtime insulin analogs accelerated their absorption. The acceleration produced by the coadministration of rHuPH20 produced significantly more pronounced insulin effects during the first hour after injection as well as a more rapid diminution of insulin effects two to four hours after administration compared to the analogs alone. The coinjection of PH20 with lispro (Humalog®), aspart (NovoLog®) and glulisine (Apidra®) results in a more physiologic fast-in, fast-out profile and enhances the glucodynamic performance for each analog. Halozyme presented these results at the American Diabetes Association 70th Scientific Sessions today in Orlando, Fla.
"Halozyme's rHuPH20 enzyme accelerates both absorption and subsequent glucodynamic effects across the board for all three approved mealtime insulin analogs," stated Douglas B. Muchmore, M.D., Halozyme's vice president of endocrinology clinical development. "We previously demonstrated that acceleration of insulin lispro absorption and action leads to meaningful improvements in the glycemic response to meals in both type 1 and type 2 diabetes. These new results indicate that rHuPH20 will confer comparable benefits to all three marketed rapid acting insulin analogs." 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.
Key Findings from the Oral Presentation Today
This trial compared the pharmacokinetic and glucodynamic effects of Apidra, Humalog, and NovoLog with and without PH20 in a six-way crossover euglycemic glucose clamp study conducted in 14 healthy subjects. Each participant received all six of the study drugs subcutaneously in random order. The trial design allows a comparison of the effect of rHuPH20 coinjection on the time-action profiles of the three analogs and provides an opportunity to observe the relative differences between them. The primary endpoint was a comparison of the insulin AUC 0-60 min (area under the curve) for each analog with and without PH20.
The three analogs without PH20 had comparable insulin time-action and time-exposure profiles. With regard to the pharmacokinetics of insulin absorption, 50% of total insulin exposure as measured by AUC occurred at 125, 123 and 131 minutes for Apidra, Humalog and NovoLog, respectively. When coadministered with PH20, the 50% of total insulin exposure times accelerated to 79, 71 and 73 minutes, respectively (all p<0.0001). Insulin exposure during the first hour (primary endpoint) increased to 191%, 229% and 246%, respectively (all p<0.0001), with coadministration of PH20 compared to each analog alone. Insulin exposure after two hours showed a decrease in the presence of PH20 of 43%, 54% and 57% compared to the analogs alone.
In terms of insulin action, glucose infusion during the first two hours increased to 157%, 161% and 182% (all p<0.0001) of control for Apidra, Humalog and NovoLog, respectively. Insulin action after four hours, indicative of a faster-off profile, decreased by 48%, 44% and 50% for the PH20 coinjection with each analog. These results demonstrate that rHuPH20 accelerates the absorption and action of all three analogs to a similar extent resulting in more physiologic fast-in, fast-out profiles. The addition of rHuPH20 improves prandial insulin absorption and action to a magnitude that is similar to the advances that the mealtime analogs as a class provided over regular insulin.
All injections were well tolerated and all adverse events were mild or moderate and considered to be procedure related. Additional information about this study, "Human Hyaluronidase Coinjection Accelerates Insulin Pharmacokinetics and Glucodynamics of 3 Rapid Insulin Analogs," can be found by visiting http://scientificsessions.diabetes.org
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze™ technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, for up to 13 targets, and with Baxter BioScience to apply Enhanze technology to GAMMAGARD Liquid®. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the benefits of insulin plus rHuPH20 combinations) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.
Robert H. Uhl
Senior Director, Investor Relations
SOURCE Halozyme Therapeutics, Inc.