Halozyme Study Results Show Faster Insulin Absorption when Administered in Combination with a Wide Range of PH20 Enzyme Concentrations
-- Faster Absorption and Greater Peak Concentrations Reported for Combinations of PH20 with Regular Insulin and Insulin Lispro Compared to Either Insulin Alone --
-- Effects of Insulin Were Accelerated with the Addition of PH20 as Measured by Glucodynamic Endpoints --
SAN DIEGO--(BUSINESS WIRE)--Oct 21, 2009 - Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced dose response study results that demonstrated faster insulin absorption and increased peak insulin concentrations after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with regular human insulin and with insulin lispro. The enhanced absorption effects were observed at clinically relevant insulin doses across a broad range of PH20 concentrations. In addition, study results also showed accelerated insulin action as measured by glucose infusion rates in this euglycemic glucose clamp study. The company presented these results today at the International Diabetes Federation Congress in Montreal.
“This study has demonstrated faster insulin absorption for varying insulin doses and PH20 concentrations. Even at relatively low insulin doses and low concentrations of PH20, the faster insulin absorption produced an acceleration of the effects of insulin,” said Doug Muchmore, M.D., vice president, endocrinology clinical development. “This dose response study allowed us to determine the optimal enzyme concentration, an important milestone in the development of our ultrafast insulin program, which has already been useful in the design of ongoing clinical trials.”
The study enrolled healthy volunteers in cohorts of four subjects who received either 3U or 12U of regular insulin or 1.5U or 6U of insulin lispro, without PH20 and with five different concentrations of PH20 during a total of six clamp procedures. The results demonstrated that PH20 is a potent enhancer of insulin absorption over a wide range of concentrations, 0.3 to 80 micrograms per mL, with an optimum effect at about 5 micrograms per mL. Observed adverse events were generally mild, and PH20 was well tolerated when co-injected with either regular human insulin or insulin lispro.
The 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). With a more rapidly absorbed, faster acting insulin product, Halozyme seeks to demonstrate one or more significant improvements relative to existing treatment, such as improved glycemic control, less hypoglycemia, and less weight gain. A number of Phase 1 and Phase 2 clinical pharmacology trials, and registration trial-enabling treatment studies are ongoing or planned, that will investigate the various attributes of Halozyme's insulin product candidates. A multidose crossover treatment study in type 1 patients is currently underway that compares regular insulin with PH20 to Humalog® (insulin lispro), where patients self-administer each test drug for three months. Results are expected in 3Q10.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based 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 for up to 13 targets and with Baxter BioScience to apply Enhanze technology to Baxter's biological therapeutic compound, GAMMAGARD Liquid®. The product candidates in Halozyme's research pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.
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In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning (i) program goals, (ii) product characteristics, (iii) other clinical trials, and (iv) clinical trial results and the conclusions drawn from such trials) 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
Posted: October 2009