Aeterna Zentaris Announces the Selection of a Development Candidate in the DC-PTH Program for the Potential Treatment of Prim...
May 06 2021 - 8:05AM
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) through its
wholly-owned subsidiary Aeterna Zentaris GmbH, (“Aeterna” or the
“Company”), a specialty biopharmaceutical company developing and
commercializing a diversified portfolio of pharmaceutical and
diagnostic products, today announced that, in consultation with The
University of Sheffield, UK (the “University”), Aeterna has
selected AEZS-150 as the lead candidate in the Company’s delayed
clearance parathyroid hormone fusion polypeptides (DC-PTH) program.
Aeterna will now start the formal preclinical development of
AEZS-150 in preparation for a potential IND filing for conducting
the first in-human clinical study of AEZS-150. AEZS-150 is being
developed with the goal of providing a potential new treatment
option of primary hypoparathyroidism in adults.
“We are very excited to have identified AEZS-150
as the development candidate within our DC-PTH program. We are in
contact with CMOs to establish the GMP manufacturing process to
prepare material for the required toxicology and safety assessment
of AEZS-150. At this point in time the Aeterna team with its proven
expertise can contribute on the formal development process of a new
chemical entity (NCE). We look forward to continuing and advancing
the development of our collaboration with the University and Prof.
Dr. Ross. We are now a step closer towards our common goal of
potentially helping patients suffering from hypoparathyroidism,”
commented Dr. Klaus Paulini, Chief Executive Officer of
Aeterna.
AEZS-150 is a DC-PTH consisting of a modified
growth hormone binding protein (GHBP) linked to PTH1-34. It is
being developed with the goal of producing a product with delayed
clearance of one or two weeks and the potential to be
self-administered via a pharmaceutical pen. If successful, it would
help patients maintain normal serum calcium and phosphate levels
during chronic use. The technology is based on proprietary
intellectual property exclusively licensed by Aeterna from the
University.
Prof. Dr. Richard J. Ross of the University
added, “We are very optimistic about the development candidate
AEZS-150 and the start of the preclinical program. We will now
focus on the further characterization of AEZS-150 in disease
specific in-vitro and in-vivo models. We are confident that Aeterna
is the right partner to pursue the manufacturing process and the
formal preclinical development.”
Primary hypoparathyroidism, the first indication
for candidate AEZS-150, is an orphan indication in the field of
endocrinology. It is an uncommon condition in which the body
produces abnormally low levels of PTH. PTH is a key regulating
hormone essential for calcium homeostasis and renal phosphate
clearance for maintaining a balance of those two minerals in the
body. Untreated, primary hypoparathyroidism will cause, among other
effects, renal dysfunction, muscle cramping, twitching, seizures,
and cardiac arrhythmias. Approximately 23 to 37 in every 100,000
individuals in Europe and the U.S. are estimated to suffer from
hypoparathyroidism.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty
biopharmaceutical company developing and commercializing a
diversified portfolio of pharmaceutical and diagnostic products
focused on areas of significant unmet medical need. The Company’s
lead product, 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). The Company is
leveraging the clinical success and compelling safety profile of
macimorelin to develop it for the diagnosis of childhood-onset
growth hormone deficiency (CGHD) in collaboration with Novo
Nordisk.Aeterna Zentaris is dedicated to the development of
therapeutic assets and has recently taken steps to establish a
growing pipeline to address unmet medical needs across a number of
indications, including neuromyelitis optica spectrum disorder
(NMOSD), primary hypoparathyroidism and neurodegenerative disease.
Additionally, the Company is developing an oral prophylactic
bacterial vaccine against SARS-CoV-2, the virus that causes
COVID-19.
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 in
this press release include those relating to the development of
AEZS-150 as a potential new therapeutic treatment option for
primary hypoparathyroidism and the effect and method of
administration of any product developed with AEZS-150.
Forward-looking statements involve known and unknown risks and
uncertainties, including those discussed in this press release and
in our Annual Report on Form 40-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 U.S. Securities and Exchange Commission. 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, results from ongoing
or planned pre-clinical and clinical studies of our other products
under development may not be successful; our ability to raise
capital and obtain financing to continue our currently planned
operations, our ability to continue to list our Common Shares on
the NASDAQ; 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 Agreements for macimorelin; the global
instability due to the global pandemic of COVID-19, and its unknown
potential effect on our planned operations; our ability to enter
into out-licensing, development, manufacturing, marketing and
distribution agreements with other pharmaceutical companies and
keep such agreements in effect; 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; 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), 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 ThomasJTC TeamT (US): +1 (833) 475-8247E:
aezs@jtcir.com
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