QUEBEC CITY, Nov. 19, 2015 /PRNewswire/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS)(TSX: AEZ) (the "Company") announced today
that the first patient has been enrolled for the Company's
confirmatory Phase 3 clinical study to demonstrate the efficacy of
Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for
use in evaluating adult growth hormone deficiency ("AGHD").
David A. Dodd, Chairman,
President and Chief Executive Officer of the Company, remarked, "We
remain committed to the development of Macrilen™ because of our
confidence in its efficacy and safety, as well as the medical need
for such a convenient test in the absence of an FDA-approved
diagnostic test for AGHD."
About the Study
The confirmatory Phase 3 clinical study of Macrilen™, entitled
Confirmatory validation of oral macimorelin as a growth hormone
(GH) stimulation test (ST) for the diagnosis of adult growth
hormone deficiency (AGHD) in comparison with the insulin tolerance
test (ITT), is designed as a two-way crossover study with
the insulin tolerance test as the benchmark comparator and will
involve some 30 sites in the United
States and Europe.
The study population will consist of approximately 110
subjects (at least 55 ITT-positive and 55 ITT-negative) with a
medical history documenting risk factors for AGHD, and will include
a spectrum of subjects from those with a low risk of having AGHD to
those with a high risk of having the condition. The primary
endpoint is validation of a single oral dose of macimorelin for the
diagnosis of AGHD, using the ITT as a comparator. The
coordinating investigator is Jose Manuel
Garcia, MD, PhD, Associate Professor of
Medicine-Endocrinology at Baylor College of
Medicine in Houston,
Texas.
Based on meetings with the US Food and Drug Administration
("FDA") as well as the European Medicines Agency ("EMA") and
subsequent written scientific advice, the Company believes that the
study meets the FDA's and the EMA's study-design expectations
allowing US and European approval, if successful.
For more details on the trial, please consult this link:
https://www.clinicaltrial.gov/ct2/show/NCT02558829?term=macimorelin&rank=1.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small
molecule that stimulates the secretion of growth hormone.
Macimorelin, under the trade name MacrilenTM, has
been granted orphan drug designation by the FDA for diagnosis of
AGHD. The Company owns the worldwide rights to this novel
patented compound.
About AGHD
AGHD affects approximately 75,000 adults across the US,
Canada and Europe. Growth hormone not only plays an
important role in growth from childhood to adulthood, but also
helps promote a hormonally-balanced health status. AGHD
mostly results from damage to the pituitary gland. It is
usually characterized by a reduction in bone mineral density, lean
body mass, exercise capacity, and overall quality of life.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. For more
information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995. Specifically, the statement
that the Company believes that the confirmatory Phase 3 study of
Macrilen™ meets the FDA's and the EMA's study-design expectations
allowing US and European approval, if the study is successful, is a
forward-looking statement. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties
include, among others, the availability of funds and resources to
pursue research and development projects and clinical trials, the
successful and timely completion of clinical studies, the risk that
safety and efficacy data from any of our Phase 3 trials may not
coincide with the data analyses from previously reported Phase 1
and/or Phase 2 clinical trials, the ability of the Company to
efficiently commercialize one or more of its products or product
candidates, the ability of the Company to take advantage of
business opportunities in the pharmaceutical industry,
uncertainties related to the regulatory process, the potential
inability to protect our intellectual property, the potential of
liability arising from shareholder lawsuits and general changes in
economic conditions. Investors should consult the Company's
quarterly and annual filings with the Canadian and US securities
commissions for additional information on risks and uncertainties
relating to forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements. The Company does not undertake to update these
forward-looking statements. We disclaim any obligation to
update any such factors or to publicly announce the result of any
revisions to any of the forward-looking statements contained herein
to reflect future results, events or developments, unless required
to do so by a governmental authority or by applicable law.
SOURCE Aeterna Zentaris Inc.