Streamlining of organization to focus on
near-term deliverables for pegtarviliase in Homocystinuria and
long-term value creation
Cortney
Caudill, M.B.A., has been promoted to the newly created role
of chief product officer to increase focus and efficiency in the
advancement of clinical programs
AUSTIN,
Texas, Jan. 6, 2023 /PRNewswire/ -- Aeglea
BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology
company developing a new generation of human enzyme therapeutics as
innovative solutions for rare metabolic diseases, today announced
an update to its corporate structure. These changes are in addition
to the restructuring process that was initiated in August 2022 and are intended to further
streamline the organization, create operational efficiencies to
support near- and long-term objectives and maximize the value of
the company's two clinical programs.
As part of these additional changes, the workforce of the
company has been further reduced by approximately 15%. Aeglea is
also halting the preclinical work on the Cystinuria and other
unnamed pipeline programs. The company will evaluate potential
strategic options for these programs in order to maximize
value.
In conjunction with these announcements, Cortney Caudill has been promoted from senior
vice president of technical operations to chief product officer,
effective January 6, 2023. In this
expanded role, Ms. Caudill will be a strategic leader, team
supervisor, and internal advocate for Aeglea's clinical programs,
helping the company focus on key deliverables and resource
allocation for both Homocystinuria and Arginase 1 Deficiency
programs. In addition, Leslie Sloan,
Ph.D., will be departing from her role as chief operating
officer.
"Since joining as CEO, my focus has been on reviewing all
aspects of the pipeline and determining the needs for achieving our
short-term objectives and enabling long-term value creation. I
believe the streamlining of the organization, the continued focus
on pegtarviliase and the promotion of Cortney into a newly created
product leadership role will help us achieve our goals in 2023 and
set us up for future success," said Jeffrey
Goldberg, president and chief executive officer of Aeglea.
"This is a critical moment of change for the company. It is
unfortunate that a group of talented and respected employees have
been impacted. We value their important contributions to the
company and are committed to provide support as they work through
this transition. While this is a difficult decision, we believe it
is in the best path to serving our most important stakeholder – the
patients and their families."
Ms. Caudill joined Aeglea in 2019 and has served as a valued
leader of the company's manufacturing, technical operations and
pegtarviliase program teams. She has over 25 years of experience in
the biotechnology and healthcare industry including leadership
roles in manufacturing, site build and startup, quality, program
management and business development. Prior to joining Aeglea, she
was the head of Baxalta's Global Drug Product External
Manufacturing Network and she was located in Zurich, Switzerland with responsibility for
over 20 commercial and pipeline products. Ms. Caudill has held
various roles of increasing responsibility at Cambrex, Vaxgen,
Genentech, Vetter Pharma and Samsung Biologics, and started her
career in the U.S. Air Force. She holds a B.S. in Biology and a
B.A. in Psychology from The University of
Texas as well as an M.B.A from Fordham
University.
"I am excited to take on this new role as we continue to focus
our efforts on enrolling the Homocystinuria trial for pegtarviliase
and advancing pegzilarginase through the regulatory process," said
Ms. Caudill. "I'm confident in the experience and knowledge of our
teams and our ability to execute in delivering on the potential of
these important programs for patients and their families."
About Pegtarviliase in Homocystinuria
Pegtarviliase is a novel recombinant human enzyme, which is
engineered to degrade the amino acid homocysteine and its dimer.
Pegtarviliase is currently being studied in a Phase 1/2 clinical
trial for the treatment of patients with Classical Homocystinuria,
a rare inherited disorder of methionine metabolism that results in
elevated levels of total homocysteine. Homocysteine accumulation
plays a key role in multiple progressive and serious
disease-related complications, including thromboembolic vascular
events, skeletal abnormalities (including severe osteoporosis),
developmental delay, intellectual disability, lens dislocation and
severe near sightedness. In preclinical studies, pegtarviliase
improved important disease-related abnormalities and survival in a
mouse model of Homocystinuria. Pegtarviliase has received both U.S.
and EU Orphan Drug Designation as well as U.S. Rare Pediatric
Disease Designation.
About Pegzilarginase in Arginase 1 Deficiency
Pegzilarginase is a novel recombinant human enzyme engineered to
degrade the amino acid arginine and has been shown to rapidly and
sustainably lower levels of the amino acid arginine in plasma.
Aeglea is developing pegzilarginase for the treatment of people
with Arginase 1 Deficiency (ARG1-D), a rare debilitating and
progressive disease characterized by the accumulation of arginine.
ARG1-D presents in early childhood and patients experience
spasticity, seizures, developmental delay, intellectual disability
and early mortality. The PEACE Phase 3 clinical trial met its
primary endpoint with a 76.7% reduction in mean plasma arginine
compared to placebo. Additionally, 90.5% of pegzilarginase treated
patients achieved normal plasma arginine levels. The arginine
lowering was accompanied by a positive trend in Gross Motor
Function Measure Part E, a measure of patient mobility.
About Aeglea BioTherapeutics
Aeglea BioTherapeutics is a clinical-stage biotechnology company
redefining the potential of human enzyme therapeutics to benefit
people with rare metabolic diseases with limited treatment options.
Aeglea is investigating pegtarviliase in an ongoing Phase 1/2
clinical trial for the treatment of Classical Homocystinuria.
Pegtarviliase has been granted Rare Pediatric Disease Designation.
Aeglea's other clinical program, pegzilarginase, achieved the
primary endpoint of arginine reduction in the PEACE Phase 3
clinical trial and has received both Rare Pediatric Disease and
Breakthrough Therapy Designations. The Marketing Authorization
Application for pegzilarginase is currently under review with the
European Medicines Agency. For more information, please visit
http://aeglea.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 our ability to achieve further cost-savings, the
timing of announcements and updates relating to our clinical trials
and related data, including the clinical data for our Phase 1/2
trial of pegtarviliase in Classical Homocystinuria, the timing and
success of our clinical trials and related data, the timing and
expectations for regulatory submissions and approvals, including
the MAA for pegzilarginase in Europe, our ability to obtain regulatory
approval for, and commercialize, pegzilarginase, recognize
milestone and royalty payments from our agreement with Immedica,
our ability to enroll patients into our clinical trials, the
expected impact of the COVID-19 pandemic on our operations and
clinical trials, success in our collaborations, the length of time
that we believe our existing cash resources will fund operations,
the potential addressable markets of our product candidates and the
potential therapeutic benefits 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 September
30, 2022 filed with the Securities and Exchange Commission
(SEC), and our 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.
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SOURCE Aeglea BioTherapeutics, Inc.