All amounts are in US dollars
QUÉBEC CITY, May 26, 2015 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that it has received written
scientific advice from the European Medicines Agency ("EMA")
regarding the further development plan, including the study design,
for the new confirmatory Phase 3 clinical study of Macrilen™
(macimorelin) for use in evaluating adult growth hormone deficiency
("AGHD"), following a Scientific Advice Meeting that was held
earlier this month. As a result of the advice, the Company
believes that the confirmatory Phase 3 study that was discussed
with the U.S. Food & Drug Administration ("FDA") last March,
meets the EMA's study-design expectations.
Dr. Richard Sachse, Chief
Scientific Officer and Chief Medical Officer of the Company stated,
"We are very pleased with the EMA's advice as we continue to
believe that our trial will confirm the efficacy and safety of this
product. In principle, the EMA agreed with our proposed protocol
design in the evaluation of the product. In addition, it proposed
that we consider additional aspects regarding the demonstration of
reproducibility of a diagnosis made using Macrilen™, which will
further enhance the profile of our compound. We believe we will be
able to provide the information that EMA requires in a timely and
cost‑effective manner."
David A. Dodd, Chairman and Chief
Executive Officer of the Company commented on the future
development of Macrilen™, "We are committed to moving
forward swiftly with the development of Macrilen™ in
AGHD. We believe that completion of the confirmatory Phase 3 study
and the QT study will take 15 to18 months and will require a
combined expenditure of between $5 million
and $6 million. We have the resources necessary to bring
this product to market and intend to do so as rapidly as possible,
pending regulatory approvals."
Study design
The multinational confirmatory efficacy Phase 3 clinical study
with Macrilen™ for the evaluation of AGHD will be conducted as a
two-way crossover study with the insulin tolerance test as the
benchmark comparator. The study population will consist of patients
with a medical history documenting risk factors for AGHD and will
include a spectrum of patients from those with a low risk of having
AGHD to those with a high risk of having the condition. The Company
will submit a proposed final protocol to the FDA for their review
prior to commencing the confirmatory efficacy Phase 3 study. A
dedicated thorough Phase 3 QT study to evaluate the effect of
Macrilen™ on myocardial repolarization is expected to be initiated
in early 2016.
About Macrilen™ (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small
molecule that stimulates the secretion of growth hormone.
Macimorelin, under the trade name Macrilen™, 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 Adult Growth Hormone Deficiency (AGHD)
AGHD affects approximately 75,000 adults across the U.S.,
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
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. 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
R&D 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 ability 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.