PHILADELPHIA, June 11, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced results from a Phase 2 study of prandial insulin formulations, which include the Company's recombinant human hyaluronidase (rHuPH20) enzyme, in patients with Type 1 diabetes. The study met its primary endpoint of A1C non-inferiority (A1C is a measure of average blood sugar over three months). Further, data from the study indicated that rHuPH20 reduced postprandial glycemic excursions, as well as significantly reduced hypoglycemic events. These findings were presented in an oral presentation at the 72nd Scientific Sessions of the American Diabetes Association (ADA) on Monday, June 11 from 6:15 - 6:30 PM EDT.
"There is a real need for faster-acting mealtime insulins. By accelerating the absorption and action of prandial insulins, rHuPH20 may help reduce mealtime glucose fluctuations that make managing diabetes difficult," said Irl B. Hirsch, M.D., Professor of Medicine, Diabetes Treatment and Teaching Chair, University of Washington School of Medicine. "This faster-in, faster-out profile may also attenuate the risk of hypoglycemia. In this study, improved control of mealtime glucose significantly reduced hypoglycemic events in patients receiving treatments with the rHuPH20 enzyme. The data further indicated that Halozyme's ultrafast insulin formulations moderate glucose swings, thus more closely mimicking the effects of endogenous insulin and, if approved, could ultimately help patients with diabetes live healthier lives."
The study compared two rapid acting insulin analog products (lispro or aspart), formulated with rHuPH20 (lispro-PH20 and aspart-PH20, each an Analog-PH20), to an active comparator (lispro alone). The study met the primary endpoint, showing that the Analog-PH20 formulations were non-inferior for A1C, compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.05, +.15). Patient groups in all treatment arms of this study achieved excellent blood glucose control, with endpoint A1C values <6.9%. Data from the study also showed that mean post-meal glycemic excursions (measured at 90 minutes) in the patient groups treated with Analog-PH20 were reduced by 82 percent (p=.0045), with more patients consistently achieving post-prandial glucose targets for at least two-thirds of their meals, as compared with the patient group treated with lispro alone. For those patient groups treated with Analog-PH20, overall hypoglycemic rates as defined by the ADA (glucose <70 mg/dL) were reduced by 5 percent (p=.035) and hypoglycemic events as defined by a more stringent definition (glucose <56 mg/dL) by 7 percent (p=.044), as compared with the patient group treated with lispro alone.
Additionally, over the 12 week study period total daily insulin dose with the Analog-PH20 treatment groups was comparable (54+27 U vs. 56+27 U, p=.057) as was weight change (-0.25 lbs. vs. +0.10 lbs., p=.27), compared with the patient group treated with lispro alone. Adverse events were also comparable between treatments, with no meaningful difference in adverse events, immunogenicity or injection site pain and Analog-PH20 was well tolerated. Treatment phase severe adverse events were limited to hypoglycemia, which occurred in two subjects treated with lispro alone.
This 30 week, randomized, double-blind, two-way cross-over safety and efficacy study compared subcutaneously injected Analog-PH20 versus lispro alone in patients with Type 1 diabetes who were an average age of 43+14 years and had been treated with insulin for > 12 months. The study enrolled 117 patients with an average Body Mass Index (BMI) of 27.3+4.0, and A1C of 7.0+.5 percent. After a four to six week run-in period using prandial glulisine plus twice-daily glargine, patients were randomized to lispro-PH20 or aspart-PH20 versus lispro alone for two, 12-week intensive management periods. Prandial therapy was administered immediately before meals. The primary endpoint of the study was A1C non-inferiority. Secondary outcomes included rates of hypoglycemia, insulin dose, change in body weight, along with blood glucose measures.
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at 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 possible benefits and attributes of our ultrafast insulin formulations) 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2012.
Media/Investor Contact: Anne Erickson Executive Director Halozyme Therapeutics 858-699-9166 [email protected]