Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the “Company”), a
specialty biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests, today announced the presentation
of results from its first pediatric study of macimorelin as a
growth hormone stimulation test for the evaluation of
childhood-onset growth hormone deficiency (“CGHD”) at the 22nd
European Congress of Endocrinology (e-ECE 2020), being held
September 5-9, 2020.
The data were presented during the event in an
ePoster titled, Pharmacokinetics and pharmacodynamics of
macimorelin acetate (AEZS-130) in paediatric patients with
suspected growth hormone deficiency (GHD), accommodated by an audio
commentary. The full poster is now available on the Company’s
website.
“We are grateful to have the opportunity to
present at the e-ECE 2020 congress. We are incredibly encouraged by
the results from this study, which demonstrated macimorelin’s
safety and tolerability, and a PK and PD profile in a range
expected from the adult development program,” commented Dr. Nicola
Ammer, Chief Medical Officer of Aeterna Zentaris. “As we advance
into our pivotal Study P02, which we expect to initiate in the
first quarter of 2021, we are confident that we have selected with
1.0 mg/kg macimorelin the correct dosing regimen based on
insights gained from the Study P01.”
The AEZS-130-P01 study (“Study P01”), was an
open-label, group comparison, dose escalation trial and the first
of two studies as agreed with the European Medicines Agency (“EMA”)
in the Company’s Pediatric Investigation Plan (“PIP”) for
macimorelin. Study P01 was designed to investigate the
pharmacokinetics (“PK”), pharmacodynamics (“PD”), safety, and
tolerability of macimorelin after single oral dosing of 0.25, 0.5,
and 1.0 mg/kg in pediatric patients with suspected growth hormone
deficiency (“GHD”).
The Company completed the study and announced
positive results in April 2020. The completed study included 24
subjects aged 4 to 15 years. In the subjects who completed the
study in accordance with the protocol, macimorelin demonstrated an
excellent safety and tolerability profile. There were 88 adverse
events (“AE”) reported in 23 subjects, none of which was assessed
by the investigator as related to macimorelin. The majority of AEs
(approximately 70%) were expected side effects related to the
hypoglycemia introduced by the Insulin Tolerance Test. No
significant changes in ECG parameters and safety laboratory values
were noted in any of the three dosing cohorts.
Abstracts for the e-ECE 2020 conference have
been published in Endocrine Abstracts. Endocrine Abstracts is an
entirely online, open-access and fully citable collection of all
the abstracts from e-ECE 2020.
For more information about Study P01, please
visit EU Clinical Trials Register and reference EudraCT
#2018-001988-23.
About e-ECE 2020
The European Congress of Endocrinology is the
European Society of Endocrinology’s premier event, attracting over
3,500 international delegates each year across the spectrum of
endocrinology. The event is a showcase of the best of science and
clinical practice across the fields of endocrinology and
metabolism, and aims to deliver to all audiences interested in the
field, whether you are an experienced consultant, a scientist or a
nurse, and whether you are well advanced in your career or just
starting out. e-ECE 2020 is this year’s fully digital Congress
bringing you the latest innovations in endocrine research and
patient care. For more information, please visit the event
website.
About Macimorelin
Macimorelin, a ghrelin agonist, is an
orally-active small molecule that stimulates the secretion of
growth hormone from the pituitary gland. Stimulated growth hormone
levels are measured in blood samples after oral administration of
macimorelin for the assessment of GHD.
In December 2017, the United States Food and
Drug Administration (“FDA”) granted Aeterna Zentaris marketing
approval for Macrilen™ to be used in the diagnosis of patients with
adult growth hormone deficiency (AGHD). Macimorelin acetate has
been granted Orphan Drug designation by the FDA for diagnosis of
GHD. In January 2019, the European Commission granted marketing
authorization for macimorelin to Aeterna Zentaris for diagnosis of
growth hormone deficiency in adults. In March 2017, the Pediatric
Committee of the EMA agreed to the Company’s PIP for macimorelin, a
prerequisite for filing a marketing authorization application for
any new medicinal product in Europe.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests. The Company’s lead product,
Macrilen™ (macimorelin), is the first and only U.S. FDA and
European Commission approved oral test indicated for the diagnosis
of adult growth hormone deficiency (AGHD). Macrilen™ is currently
marketed in the United States through a license agreement with Novo
Nordisk and Aeterna Zentaris receives double-digit royalties on
sales. Aeterna Zentaris owns all rights to macimorelin outside of
the U.S. and Canada.
Aeterna Zentaris is also leveraging the clinical
success and compelling safety profile of macimorelin to develop it
for the diagnosis of childhood-onset growth hormone deficiency
(CGHD), an area of significant unmet need.
The Company is actively pursuing business
development opportunities for the commercialization of macimorelin
in Europe and the rest of the world, in addition to other
non-strategic assets to monetize their value. For more information,
please visit www.zentaris.com and connect with the Company on
Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains forward-looking
statements (as defined by applicable securities legislation) 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 regarding the
timeline of the initiation of the Study P02 and include statements
preceded by, followed by, or that include the words "will,"
"expects," "believes," "intends," "would," "could," "may,"
"anticipates," and similar terms that relate to future events,
performance, or our results. Forward-looking statements involve
known and unknown risks and uncertainties, including those
discussed in our Annual Report on Form 20-F, under the caption "Key
Information - Risk Factors" filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the SEC, and other factors discussed under the
heading “Risk Factors” in the Company’s Registration Statement on
Form F-1 (File No. 333-232935) filed with the SEC and other
documents subsequently filed with or furnished to the SEC. 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, our ability to raise
capital and obtain financing to continue our currently planned
operations, our ability to regain compliance with the continued
listing requirements of the NASDAQ and continue to list our Common
Shares on the NASDAQ, our ability to continue as a going concern is
dependent, in part, on our ability to transfer cash from Aeterna
Zentaris GmbH to Aeterna Zentaris and the U.S. subsidiary and
secure additional financing, our now heavy dependence on the
success of Macrilen™ (macimorelin) and related out-licensing
arrangements and the continued availability of funds and resources
to successfully commercialize the product, including our heavy
reliance on the success of the License Agreement with Novo, the
global instability due to the global pandemic of COVID-19, and its
unknown potential effect on our planned operations, including
studies, our ability to enter into out-licensing, development,
manufacturing, marketing and distribution agreements with other
pharmaceutical companies and keep such agreements in effect, our
reliance on third parties for the manufacturing and
commercialization of Macrilen™ (macimorelin), potential disputes
with third parties, leading to delays in or termination of the
manufacturing, development, out-licensing or commercialization of
our product candidates, or resulting in significant litigation or
arbitration, uncertainties related to the regulatory process,
unforeseen global instability, including the instability due to the
global pandemic of the novel coronavirus, our ability to
efficiently commercialize or out-license Macrilen™ (macimorelin),
our reliance on the success of the pediatric clinical trial in the
European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin), the
degree of market acceptance of Macrilen™ (macimorelin), our ability
to obtain necessary approvals from the relevant regulatory
authorities to enable us to use the desired brand names for our
product, our ability to successfully negotiate pricing and
reimbursement in key markets in the E.U. for Macrilen™
(macimorelin), any evaluation of potential strategic alternatives
to maximize potential future growth and shareholder value may not
result in any such alternative being pursued, and even if pursued,
may not result in the anticipated benefits, 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 our quarterly and
annual filings with the Canadian and U.S. securities commissions
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.
Investor Contact:
Jenene Thomas JTC Team T (US): +1 (833) 475-8247 E:
aezs@jtcir.com
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