Presentation by Dr. Jose M. Garcia concludes that Macrilen™ is a
simple, well-tolerated, reproducible and safe diagnostic test for
adult growth hormone deficiency
Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZ) (the
“Company”) today announced that Jose M. Garcia, M.D., Ph.D., an
Associate Professor of Medicine at the Puget Sound Veterans
Administration Hospital and the University of Washington, will
present an abstract entitled “Validation of Macimorelin as a
Diagnostic Test for Adult Growth Hormone Deficiency (AGHD): A Phase
3 Study in Comparison with the Insulin Tolerance Test (ITT)” from
1:00 pm through 3:00 pm E.T. on Sunday, April 1, 2017 at the 99th
Annual Meeting of the Endocrine Society in Orlando, Florida.
In the abstract, Dr. Garcia and the co-authors of the abstract
conclude, based on their review of the data from the confirmatory
Phase 3 study of Macrilen™, that growth hormone stimulation with
macimorelin is a simple, well-tolerated, reproducible and safe
diagnostic test for AGHD, with comparable accuracy to that of the
ITT and that macimorelin results in a more potent growth hormone
stimulatory release compared to the ITT. Dr. Garcia will present
his conclusion to the US Food and Drug Administration (“FDA”) at
the end of March 2017 at a meeting arranged by the Company. The
Company will seek the FDA’s concurrence with the Company’s opinion
that Macrilen™ demonstrated performance supportive of achieving
registration.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin receptor agonist, is an orally-active
small molecule that stimulates the secretion of growth hormone.
Macimorelin has been granted orphan drug designation by the FDA for
diagnosis of AGHD. The Company owns the worldwide rights to this
patented compound and has significant patent protection left. The
Company’s U.S. composition of matter patent expires in 2022 and its
U.S. utility patent runs through 2027. The Company proposes,
subject to FDA approval, to market macimorelin under the tradename
Macrilen™.
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), was designed as a two-way crossover study with the ITT
as the benchmark comparator and involved some 26 sites in the
United States and Europe. The trial involved 157 subjects, of whom
140 completed two evaluable tests for AGHD using both Macrilen™ and
the ITT. Thirty-four of the patients were evaluated using Macrilen™
a second time to measure the repeatability of the result obtained
using Macrilen™ as the evaluation method. The study population
consisted of 115 patients who were suspected of having AGHD as a
result of the presence of one or more symptoms or risk factors.
This segment of the population included a range of patients from
those considered at low risk of having AGHD to those considered at
high risk. The study population also included 25 healthy subjects,
who had no known risk of having AGHD. Under the study protocol, the
evaluation of AGHD with Macrilen™ will be considered successful, if
the lower bound of the two-sided 95% confidence interval (or lower
bound of the one-sided 97.5% confidence interval) for the primary
efficacy variables is 75% or higher for “percent negative
agreement”, and 70% or higher for the “percent positive agreement”.
Dr. Jose M. Garcia, MD, PhD, an Associate Professor of Medicine at
the Puget Sound VA Hospital and the University of Washington in
Seattle, was the principal investigator of the confirmatory Phase 3
clinical trial. More details about the trial are available at the
following link:
https://www.clinicaltrials.gov/ct2/show/NCT02558829?term=macimorelin&rank=1.
We announced the top-line results from the confirmatory Phase 3
study on January 4, 2017. In the announcement, we stated that,
while the estimated percent negative agreement met the success
criteria, the estimated percent positive agreement did not reach
the criteria for a successful outcome. We believe that the
estimated percent negative agreement is considered as the more
relevant endpoint, and that, therefore, the study demonstrated that
the Macrilen™ test provides medical benefit.
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 as well as an increase of cardiovascular
risks.
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. We are engaged in drug
development activities and in the promotion of products for others.
We recently completed Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition of licenses to products that are relevant to our
therapeutic areas of focus. We also intend to license out certain
commercial rights of internally developed products to licensees in
non-US territories where such out-licensing would enable us to
ensure development, registration and launch of our product
candidates. Our goal is to become a growth-oriented specialty
biopharmaceutical company by pursuing successful development and
commercialization of our product portfolio, achieving successful
commercial presence and growth, while consistently delivering value
to our shareholders, employees and the medical providers and
patients who will benefit from our products. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. Forward-looking statements
may include, but are not limited to statements preceded by,
followed by, or that include the words “expects,” “believes,”
“intends,” “anticipates,” and similar terms that relate to future
events, performance, or our results. Forward-looking statements
involve known risks and uncertainties, many of which are discussed
under the caption “Key Information – Risk Factors” in our most
recent Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission (“SEC”).
Such statements include, but are not limited to, statements about
the progress of our research, development and clinical trials and
the timing of, and prospects for, regulatory approval and
commercialization of our product candidates, the timing of expected
results of our studies, anticipated results of these studies,
statements about the status of our efforts to establish a
commercial operation and to obtain the right to promote or sell
products that we did not develop and estimates regarding our
capital requirements and our needs for, and our ability to obtain,
additional financing. Known and unknown risks and uncertainties
could cause our actual results to differ materially from those in
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue our
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 rejection or non-acceptance of
any new drug application by one or more regulatory authorities and,
more generally, uncertainties related to the regulatory process
(including whether or not the regulatory authorities will accept
the Company’s conclusions regarding Macrilen™ following its
comprehensive review of the Phase 3 study data described elsewhere
in this press release), the ability of the Company to efficiently
commercialize one or more of its products or product candidates,
the degree of market acceptance once our products are approved for
commercialization, our ability to take advantage of business
opportunities in the pharmaceutical industry, our ability to
protect our intellectual property, and 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 securities commissions and the SEC
for additional information on risks and uncertainties. Given these
uncertainties and risk factors, readers are cautioned not to place
undue reliance on these forward-looking statements. We disclaim any
obligation to update any such factors or to publicly announce 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 applicable law.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170302006253/en/
Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
Presidentir@aezsinc.com
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Apr 2023 to Apr 2024
