Halozyme's Phase 2 Insulin-PH20 Study Demonstrates Faster Insulin Absorption and Superior Glucose Control in Type 1 Diabetic Patients
-- Insulin-PH20 combination significantly reduced post-meal blood glucose concentration relative to treatment target resulting in reduced hyperglycemia --
-- Significantly faster insulin absorption and greater peak insulin concentration observed for Insulin-PH20 combination compared to a best in class insulin analog --
-- Phase 2 treatment study with three times per day mealtime dosing underway --
SAN DIEGO--(BUSINESS WIRE)--Jun 6, 2009 - Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced Phase 2 results that demonstrated faster insulin absorption and increased peak insulin concentrations in type 1 diabetic patients after co-administration of its recombinant hyaluronidase enzyme (PH20) with Humalog® (insulin lispro), a mealtime insulin analog. Study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal, with improvements in both peak glycemic response and total hyperglycemic exposure compared to Humalog alone. Mean glucose levels after the meal challenge remained within current treatment targets throughout the eight hour post meal observation period. The company presented these results at the American Diabetes Association (ADA) 69th Scientific Sessions today in New Orleans.
In addition, Halozyme announced that its first treatment study with three times per day mealtime dosing of Insulin-PH20 in type 1 diabetic patients began in May, ahead of the company's previous guidance for a fourth quarter 2009 start date.
“The faster and shorter blood insulin concentration profile observed for Humalog plus PH20 in this study conducted in type 1 diabetic patients confirms our previous findings seen in healthy volunteers. The shift in the pharmacokinetics of Humalog with PH20 confers a more physiologic insulin profile and results in lower hyperglycemia after a meal,” stated Jonathan Lim, M.D., Halozyme's president & CEO. “A more rapidly acting insulin may lead to such patient benefits as fewer incidences of hypoglycemia, insulin dose reduction, greater patient convenience, and less weight gain.” The goal of Halozyme's Insulin-PH20 program is to develop a rapid and short-acting insulin product that would more closely mimic the mealtime insulin release that occurs in non-diabetics that could lead to improved treatment for diabetes patients.
ADA Presentation Focused on Humalog, Humulin® R Data to Come
This Phase 2 study investigated the pharmacokinetics (PK) and glucodynamics (GD) of Humalog and Humulin R with and without Halozyme's PH20 enzyme in 21 type 1 diabetic patients. The results presented today at ADA are for the Humalog portion of the study. Additional results from this study for Humulin R alone and in combination with PH20 have been accepted for presentation at the European Association for the Study of Diabetes (EASD) meeting in the fall.
After fasting and refraining from insulin treatment for 12 hours, patients were titrated to a stabilized 100 mg/dL glucose target with intravenous (IV) glucose and/or insulin. The same optimized dose of insulin lispro (mean 5.7 IU) with and without PH20 enzyme was injected subcutaneously (SC) immediately before a standard meal of 12 oz. Ensure and plasma insulin and glucose concentrations were monitored for 8 hours. The primary endpoint was a PK measure of area under the curve (AUC0-60) for insulin during the first 60 minutes after the SC injection. Secondary endpoints included other PK measures, glucose excursion outside of the selected target range and hypoglycemia.
Key Findings Described in the Poster Presentation Today
This clinical trial met the primary endpoint and demonstrated faster systemic insulin absorption, greater peak exposure, greater early and reduced late postprandial exposure, and a significant reduction in postprandial hyperglycemia without significant change in hypoglycemia risk. All injections were well tolerated.
Review of Insulin-PH20 Clinical Trials
A number of clinical trials investigating Halozyme's Insulin-PH20 are currently underway and more trials are planned.
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.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, (i) statements concerning the efficacy and benefits of insulin plus PH20 combinations, (ii) clinical trial results and the conclusions drawn from such trials, and (iii) the initiation and completion of 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
Posted: June 2009