- Study in type 1 diabetes patients demonstrates comparable A1C outcomes, glycemic excursions and hypoglycemia rates for Insulin-PH20 and lispro -
SAN DIEGO, Nov. 12, 2010 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced Phase 2 results demonstrating that Insulin-PH20 (recombinant human insulin with rHuPH20) produced glycemic control comparable to lispro, a widely prescribed prandial (mealtime) insulin analog. The overall safety and adverse event profiles for the two agents were comparable and both treatments were well tolerated. Insulin-PH20 achieved the primary endpoint of non-inferiority for glycemic excursions relative to lispro alone in this study conducted in a take-home diabetes treatment setting. This study represents the first reported experience in a clinical trial where patients received Halozyme's recombinant human hyaluronidase enzyme, rHuPH20, three times daily for 12 weeks for a total of over 10,000 doses of enzyme with insulin. Halozyme presented these results today at the Diabetes Technology Society meeting in Bethesda, Md.
"Halozyme has demonstrated that the combination of its PH20 enzyme with recombinant human insulin accelerates the pharmacokinetic profile to that of the currently marketed prandial analogs. The combination produces treatment effects and a safety profile comparable to the analog insulin lispro," stated Doug Muchmore, M.D., vice president of endocrinology clinical development. "The glycemic excursion results, occurrence of hypoglycemia, and reported adverse events were comparable for the two test treatments. We look forward to the results of ongoing Phase 2 studies that we anticipate will demonstrate the superiority of analog insulin with PH20 compared to analog insulin alone." 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.
"The increasing use of continuous glucose monitoring has revealed a vital unmet need for a faster acting prandial insulin to improve post-prandial glucose control," stated Satish K. Garg, M.D., Professor of Medicine and Pediatrics at the Adult Clinic of the Barbara Davis Center for Diabetes of the University of Colorado Denver, School of Medicine, and an investigator in this Phase 2 clinical trial. "The PH20 technology effectively enhanced the action of recombinant human insulin in this study. If the ongoing Phase 2 studies with the analog insulin plus PH20 combination show an even faster onset of action profile, this could significantly improve diabetes management."
Key Findings from the Poster Presentation Today
This open-label Phase 2 clinical trial compared recombinant human insulin+PH20 to lispro alone in 41 type 1 diabetes patients who self-administered their insulin on an out-patient basis. After a one month observation period that included dose optimization, patients were randomized to recombinant human insulin+PH20 or lispro and treated for 12 weeks. At the end of 12 weeks, the patients crossed over to the other study treatment for another 12 weeks.
The primary endpoint compared the average glycemic excursion for the two study drugs over three consecutive days during the final two weeks of each treatment period. The results showed glycemic excursion of 17 +/- 36 mg/dL for Insulin-PH20 and 14 +/- 35 mg/dL for lispro (P=NS) and met the prespecified noninferiority margin of 21.6 mg/dL. A1C measures were comparable for both treatments with 7.0 +/- 0.5 for Insulin-PH20 and 6.9 +/- 0.6 for lispro. The upper 95% confidence interval for the A1C difference between treatments was 0.23%, a value that meets the commonly applied noninferiority margin of 0.4% for A1C treatment group comparisons. The overall rates observed for hypoglycemia were comparable with 24.1 events/final 4 weeks of treatment for Insulin-PH20 and 22.4 events/final 4 weeks for lispro (P=NS). Adverse drug reactions were mild and rare and no meaningful immunogenicity to insulin or to rHuPH20 was observed.
Meal studies previously reported by Halozyme in type 1 and type 2 diabetes patients demonstrated that the addition of PH20 produced an acceleration of recombinant human insulin pharmacokinetics (PK) to profiles that were comparable to insulin lispro. The addition of PH20 to lispro also produced a PK profile acceleration relative to that of lispro alone. In these studies, recombinant human insulin+PH20 produced prandial glucose responses similar to lispro alone, while lispro with PH20 had improved prandial glucose control relative to lispro alone. This treatment study reported today provides confirmation that the faster PK profile for recombinant human insulin+PH20 produced glycemic control comparable to the analog insulin lispro alone in an extended take-home diabetes treatment setting. Studies currently underway are designed to show that the addition of PH20 to the analog insulins, aspart and lispro, could demonstrate meaningful improvement for the combination treatments relative to lispro alone.
Ongoing Ultrafast Insulin Clinical Trials
Two additional clinical trials investigating Halozyme's Ultrafast Insulin are underway.
- Type 1 and type 2 analog treatment studies – These Phase 2 clinical trials compare three times daily dosing for analog insulin with and without rHuPH20 with one study being conducted in type 1 patients and the other in type 2 patients. The design includes a one month observation period for dose optimization, after which patients are randomized to analog insulin alone, or analog insulin+PH20. At the end of 12 weeks, patients crossover to the other study treatment for another 12 weeks. The treatment arms utilize aspart-PH20 compared to lispro and lispro-PH20 compared to lispro. The study will evaluate safety and efficacy and patients self-administer their insulin on an out-patient basis. These studies began during 3Q2010 and additional information may be found at clinicaltrials.gov using the identifiers NCT01194245 and NCT01194258.
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 immunoglobulin. 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, (i) the benefits and superiority of insulin plus rHuPH20 combinations and their impact on diabetes management, (ii) conclusions drawn from clinical trials, and (iii) the timing and anticipated results for future clinical 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
SOURCE Halozyme Therapeutics, Inc.