PH20-prandial insulin analogs achieve primary HbA1C endpoint with superior management of post-prandial glucose compared to the insulin analogs available today
SAN DIEGO, Oct. 21, 2011 /PRNewswire via COMTEX/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced positive results from two Phase 2 clinical trials of its ultrafast PH20 insulin analog formulations in patients with Type 1 and Type 2 diabetes. Both trials met the primary endpoint of non-inferiority of HbA1C compared to the insulin analog comparator, with superior reductions in post-prandial glucose excursions in the PH20 insulin analog arms. Compared to insulin analog alone, PH20 insulin analog use resulted in a greater than 50% increase in the proportion of patients able to consistently achieve AACE (American Association of Clinical Endocrinologists) guidelines for post-prandial glucose targets in both Type 1 and Type 2 patients. Across all of the treatment groups, there was no meaningful difference in hypoglycemia incidence or event rates. Hypoglycemia events were generally mild, and adverse events with PH20 insulin analog formulations were similar to those observed during the insulin analog comparator phase.
"For patients living with diabetes, improved glycemic control is an important step towards maintaining good health," said Gregory Frost, Ph.D., Halozyme's president and CEO. "We are pleased to see that the combination of rHuPH20 with analog insulins enabled superior reductions in mealtime glucose swings and we look forward to presenting the full results of these studies at a medical conference in 2012."
Study Design Overview
Results are from two Phase 2 ultrafast insulin treatment studies, one in type 1 diabetes patients and one in type 2 patients, that compared two ultrafast insulin analog products formulated with rHuPH20 (Lispro-PH20 or Aspart-PH20) to an active comparator, Humalog (insulin lispro). More than 110 patients enrolled in each of the trials and received an insulin analog alone and one of the Analog-PH20 treatments for 12 weeks along with basal insulin glargine.
The primary endpoint of each study was a comparison of glycemic control, the main measurement that diabetes patients use to assess treatment effectiveness, as assessed by the change in HbA1C from baseline. Data regarding post-prandial glucose levels, the proportion of patients that safely achieve HbA1C targets, rates of hypoglycemia, weight change and additional endpoints were collected as well.
The Company is planning a complete presentation of the data at a major medical meeting in 2012. Halozyme intends to explore opportunities that could maximize the global availability of its injectable PH20 insulin analog therapy to patients with Type 1 and Type 2 diabetes. The Company also has an ongoing study in patients with type 1 diabetes that use insulin pumps to determine if a single dose of rHuPH20 administered at the beginning of each subcutaneous infusion of analog insulin may reduce the variability of insulin absorption over infusion set life. It is hypothesized that more responsive and predictable insulin absorption over infusion set life may enable patients to further reduce glucose excursions on pump therapy. Results from this pre-administration feasibility pharmacokinetic and meal study will be presented next week at the Diabetes Technology Meeting (DTS) on Thursday, October 27, 2011 from 4:05 to 6:30 p.m. PDT.
The HbA1C test is a common blood test used to diagnose type 1 and type 2 diabetes and then to gauge how well a patient's diabetes is being managed. HbA1C reflects average blood sugar level over a prolonged period of time. Specifically, the test measures the percentage of a person's hemoglobin (a protein in red blood cells that carries oxygen) that is coated with sugar (glycated). The higher the HbA1C level, the poorer one's blood sugar control and, for some diabetic patients, the higher the risk of diabetes complications.
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the insulin, cancer, 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(TM) technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche, Baxter, ViroPharma and Intrexon to apply Enhanze(TM) technology to therapeutic biologics including Herceptin®, MabThera®, immunoglobulin, Cinryze® and recombinant human alpha 1-antitrypsin. 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 http://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 the timing, scope and outcomes of our clinical trials as well as expected activities under our collaborative partnerships) 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 clinical trial enrollment and results, 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.
Chief Financial Officer
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