Aeterna Zentaris Concludes Successful Meeting of Clinical Investigators for Confirmatory Phase 3 Trial of Macrilen™
January 19 2016 - 8:30AM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the
“Company”) announced today that it concluded a successful meeting
of the clinical investigators for the confirmatory Phase 3 trial of
Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for
use in evaluating adult growth hormone deficiency (“AGHD”). As a
result, the Company is confident that it will complete the
confirmatory trial by year-end 2016.
Dr. Richard Sachse, the Company’s Chief Scientific Officer
stated, “On January 16, we held an Investigators’ Meeting for our
multi-center confirmatory Phase 3 clinical trial of Macrilen™. The
purpose of the meeting was to review Macrilen™ with the
investigators, as well as the clinical trial protocol. The 77
investigators and site personnel who attended the meeting included
Jose Manuel Garcia, MD, PhD, Associate Professor of Medicine at
University of Washington School of Medicine, Seattle, who is
serving as coordinating investigator. Dr. Garcia expressed his
commitment to the development of Macrilen™ because of the medical
need for such a convenient test in the absence of an FDA-approved
diagnostic test for AGHD.”
Patients who are believed to have AGHD are now very often
evaluated by means of the insulin tolerance test (“ITT”). The ITT
is the historical gold standard for the evaluation of AGHD because
of its high sensitivity and specificity. However, the ITT is
inconvenient to the patients and physicians and contra-indicated in
certain patients, such as patients with coronary heart disease or
seizure disorder, because it requires the patient to experience
hypoglycemia to obtain a result. Some physicians will not induce
full hypoglycemia, intentionally compromising accuracy to increase
safety and comfort for the patient. Furthermore, administration of
the ITT is expensive because the patient must be constantly
monitored by a physician for the 2-4 hour duration of the test and
the test must be administered in a setting where emergency
equipment is available and where the patient may be quickly
hospitalized. The ITT is not used for patients with co-morbidities,
such as CV, seizure disorder or a history of brain cancer or for
patients who are elderly and frail, due to safety concerns.
The Company believes that Macrilen™, if it is approved, is
likely to be rapidly adopted by physicians as the preferred means
of evaluating AGHD for the following reasons:
- it is safer than the ITT because it
does not require the patient to become hypoglycemic;
- Macrilen™ is administered orally, while
the ITT requires an intravenous infusion of insulin;
- the evaluation of AGHD using Macrilen™
is much less time consuming and labor intensive than the ITT and,
therefore, it is less expensive to conduct; and
- the evaluation can be conducted in the
physician’s office rather than in a hospital setting.
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. 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. As of the date of this release, five patients at three
separate centers have been enrolled in the study. For more details
on the trial, please consult this link:
https://www.clinicaltrial.gov/ct2/show/NCT02558829?term=macimorelin&rank=1.
Based on the current rate of enrollment, the Company expects the
confirmatory Phase 3 clinical study of Macrilen™ to be concluded by
the end of 2016. The Company further expects to be able to submit a
New Drug Application for Macrilen™ to the FDA by mid-year 2017 and,
if the study is successful in meeting its primary endpoint, to
obtain approval of the drug by year-end 2017.
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. We are engaged in drug
development activities and in the promotion of products for others.
We are now conducting 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
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 provisions of the US Securities
Litigation Reform Act of 1995. 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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160119005463/en/
Aeterna Zentaris Inc.Philip A. TheodoreSenior Vice
President843-900-3223ir@aezsinc.com
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