Aeglea BioTherapeutics Doses Two Patients in Repeat Dose Part of Phase 1/2 Clinical Trial for the Treatment of Arginase 1 Def...
September 06 2017 - 7:00AM
Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE) a biotechnology company
committed to developing enzyme-based therapeutics in the field of
amino acid metabolism to treat rare genetic diseases and cancer,
today announced that it has dosed two adults in the repeat dose
part of its Phase 1/2 clinical trial of AEB1102 (pegzilarginase)
for the treatment of patients with Arginase 1 Deficiency.
Initial results from two adult patients enrolled in Part 1 of
the trial, who were administered single ascending doses,
demonstrated that pegzilarginase was well tolerated and reduced
arginine levels in the blood.
“The initiation of the repeat dose part of the study is
important given the encouraging initial results seen with single
doses of pegzilarginase, as it will provide important insights into
the effects of longer term arginine reduction in patients with this
serious and progressive disease,” said James Wooldridge, M.D.,
chief medical officer of Aeglea. “Additionally, we are continuing
our discussions with the FDA about including pediatric patients in
the trial, and have initiated activities in Europe and Canada to
reach more patients with this very rare disease.”
“Although we have followed patients with Arginase 1 Deficiency
for many years, we still have very little to
offer these patients with a progressive
neurological disease. We have therefore committed to help
investigate pegzilarginase as a possible treatment option. Our
patients are also excited about our working toward a
treatment,” said Roberto Zori, M.D., professor and chief of the
Division of Genetics and Metabolism at the University of Florida
and an investigator in the trial.
About the Trial
The Phase 1/2, multicenter, single arm, open label, trial of
AEB1102 will enroll at least 10 patients, adult and pediatric, with
Arginase 1 Deficiency. The primary endpoint of the trial is
safety and tolerability of intravenous administration of
pegzilarginase in patients with Arginase 1 Deficiency. The trial
will also evaluate the pharmacokinetic and pharmacodynamic effects
of repeated doses of pegzilarginase including plasma arginine
levels.
Please visit www.clinicaltrials.gov for more information.
About AEB1102 in Arginase 1 Deficiency
AEB1102 (pegzilarginase) is an engineered human arginase 1
enzyme designed to degrade the amino acid arginine. Aeglea is
developing pegzilarginase to treat arginine excess in patients with
Arginase 1 Deficiency, a urea cycle disorder caused by a mutation
in the arginase 1 gene that leads to the inability to degrade
arginine. Pegzilarginase is intended for use as enzyme replacement
therapy to restore the function of arginase 1 in patients by
returning elevated blood arginine levels to the normal
physiological range. Aeglea is currently recruiting patients for
its ongoing Phase 1/2 trial for the treatment of Arginase 1
Deficiency. Data from the Phase 1 portion of the trial demonstrated
that pegzilarginase has the ability to reduce blood arginine
levels, providing initial human proof of mechanism.
About Aeglea BioTherapeutics
Aeglea is a biotechnology company committed to developing
enzyme-based therapeutics in the field of amino acid metabolism to
treat rare genetic diseases and cancer. The company’s engineered
human enzymes are designed to modulate the extremes of amino acid
metabolism in the blood to reduce toxic levels of amino acids in
inborn errors of metabolism or target tumor metabolism for cancer
treatment. AEB1102, Aeglea’s lead product candidate, is currently
being studied in two ongoing Phase 1 clinical trials in patients
with advanced solid tumors and acute myeloid
leukemia/myelodysplastic syndrome (AML/MDS). Additionally, Aeglea
is recruiting patients into its ongoing Phase 1/2 trial of AEB1102
for the treatment of patients with Arginase 1 Deficiency. The
company is building a pipeline of additional product candidates
targeting key amino acids, including AEB4104, which degrades
homocystine, a target for an inborn error of metabolism, as well as
two potential treatments for cancer, AEB3103, which degrades
cysteine, and its oxidized form cystine, and AEB2109, which
degrades methionine.
For more information, please
visit http://aegleabio.com.
Safe Harbor / Forward Looking Statements
This press release contains "forward-looking" statements within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: "anticipate,"
"intend," "plan," "goal," "seek," "believe," "project," "estimate,"
"expect," "strategy," "future," "likely," "may," "should," "will"
and similar references to future periods. These statements are
subject to numerous risks and uncertainties that could cause actual
results to differ materially from what we expect. Examples of
forward-looking statements include, among others, statements we
make regarding the timing and success of our clinical trials, and
economic value of our lead product candidate or other product
candidates. Further information on potential risk factors that
could affect our business and its financial results are detailed in
our most recent Quarterly Report on Form 10-Q for the quarter
ended June 30, 2017 filed with the Securities and
Exchange Commission (SEC), and other reports as filed with
the SEC. We undertake no obligation to publicly update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Media Contact:
Kelly Boothe, Ph.D.
Pure Communications
415.946.1076
media@aegleabio.com
Investor Contact:
Charles N. York II
Chief Financial Officer
Aeglea BioTherapeutics
investors@aegleabio.com
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