-- Significantly reduced variability observed for early absorption of lispro
with PH20 during the clinically important first two hours after subcutaneous
injection compared to lispro alone --
-- Variability during the first 30 minutes after injection significantly lowered
for regular human insulin with PH20 compared to lispro alone --
-- Glucodynamic variability also showed numerically favorable reduction for
lispro with PH20 compared to lispro alone --
SAN DIEGO--(Business Wire)--
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced insulin variability
study results that demonstrated reduced intrasubject absorption variability for
the combination of lispro, a meal time analog insulin, plus PH20 (hyaluronidase)
compared to subcutaneous injection of lispro alone. When compared to lispro
alone, the combination of lispro with PH20 reduced the variability for early and
late insulin absorption, the time to maximum concentration (Tmax), and the area
under the curve (AUC) at 15, 30, 60 and 120 minutes. The variability for maximum
concentration (Cmax) was not affected. In addition, study results confirmed
previously reported acceleration for both insulin absorption and action by
coadministration of PH20. The company presented these study results this evening
at the Diabetes Technology Society meeting in San Francisco.
"Reduced variability for the combination of lispro with PH20 across a number of
key pharmacokinetic measures, especially during the first two hours after
administration, is an exciting clinical result," said Doug Muchmore, M.D., vice
president, endocrinology clinical development. "For diabetes patients this could
mean more consistent and predictable insulin effects for meal time insulin
injections."
The study enrolled 22 healthy subjects who received two doses of three different
treatments: insulin lispro alone, regular insulin with PH20, and insulin lispro
with PH20 in a euglycemic glucose clamp trial design. All subjects underwent six
clamp procedures. This study reported intrasubject variability for Tmax for
lispro alone of 11 minutes, 11 minutes (ns) for regular human insulin, and four
minutes (p<.01) for the combination of lispro with PH20. Variability for AUC
during the first 30 minutes after injection was 41% for lispro alone but
improved to 24% (p<.01) for regular insulin with PH20 and 14% (p<.001) for
lispro with PH20. Overall, data were presented demonstrating that timing and
degree of insulin absorption between doses administered to the same subjects on
different occasions were more consistent when combined with PH20 than for either
insulin administered alone.
Intersubject variability for pharmacokinetic (PK) and glucodynamic (GD) measures
in the study showed a favorable trend for the combination lispro with PH20
compared to lispro. The study was not designed to test statistical significance
for intersubject variability. Intrasubject variability for GD measures in the
study also demonstrated favorable trends for the combination of lispro with PH20
compared to lispro alone, and one endpoint measure, the percent of total glucose
administered during the first four hours, reached statistical significance.
Coadministration of PH20 with both regular insulin and lispro was well
tolerated.
Also this evening at the Diabetes Technology Society, Halozyme presented
additional new data from the dose-ranging study first shown at the International
Diabetes Federation Congress last month. These additional data again confirmed
that PH20 at the optimized dose of 5 μg/100 U of insulin accelerated the
absorption and action of insulin. Furthermore, PH20 improved the PK dose
proportionality responses to prandial insulins across a range of physiologically
relevant doses, including 2 to 20 U for insulin lispro and 6 to 24 U for human
insulin.
The primary 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.
Safe Harbor Statement
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.
Halozyme Therapeutics, Inc.
Robert H. Uhl
Senior Director, Investor Relations
858-704-8264
ruhl@halozyme.com
Copyright Business Wire 2009
