Ascendis Pharma Presents TransCon™ PTH (palopegteriparatide) Phase 3 52-Week Skeletal Dynamics Data at ASBMR 2023
16 Octubre 2023 - 3:01PM
Ascendis Pharma A/S (Nasdaq: ASND) shared 52-week data from the
open-label extension period of its ongoing Phase 3 PaTHway Trial of
TransCon PTH (palopegteriparatide) showing that adults with chronic
hypoparathyroidism, whose bones tend to be over-mineralized due to
insufficient parathyroid hormone (PTH) exposure, trended toward a
new skeletal steady state closer to age-appropriate norms with
continued use of TransCon PTH. The results were consistent
regardless of sex, menopausal status, or duration of disease and
were consistent with results previously reported through Week 110
in the Company’s Phase 2 PaTH Forward Trial.
An oral presentation of the data was given today by Aliya Khan,
M.D., Clinical Professor of Medicine at McMaster University and
Director of the Calcium Disorders Clinic at McMaster University
Medical Center, during ASBMR 2023, the annual meeting of the
American Association of Bone & Mineral Research in Vancouver,
BC, Canada.
Reflecting on the clinical data and its potential impact, Dr.
Khan said “Treatment with TransCon PTH in this clinical trial
showed the positive physiological effects on bone, in patients
treated for the full year as well as in those switching from
placebo after the 26-week blinded period. These results underscore
the importance of providing the missing hormone to address the
significant impacts of hypoparathyroidism, including decreased bone
remodeling leading to a dense, over-mineralized bone
structure.”
TransCon PTH (palopegteriparatide) is an investigational prodrug
with sustained release of active parathyroid hormone (PTH [1-34])
administered once daily. On September 14, 2023, TransCon PTH
received a positive CHMP opinion recommending approval in the
European Union for the treatment of adults with chronic
hypoparathyroidism. TransCon PTH is also in development in the
United States and Japan.
PaTHway is an ongoing Phase 3 double-blind, placebo-controlled
trial of 82 dosed adults with chronic hypoparathyroidism randomized
3:1 (TransCon PTH:placebo) treated for 26 weeks, followed by a
156-week open-label extension period.
Registered attendees of ASMBR 2023 conference can access the
abstract, poster, and presentation (#1114) through the conference
organizer’s website.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative platform technology to build a leading,
fully integrated biopharma company focused on making a meaningful
difference in patients’ lives. Guided by its core values of
patients, science and passion, the company uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Germany (Heidelberg and Munich) and the United States
(Palo Alto and Redwood City, California, and Princeton, New
Jersey). Please visit ascendispharma.com to learn more.
Forward-Looking Statements This press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of
historical facts, included in this press release regarding
Ascendis’ future operations, plans and objectives of management are
forward-looking statements. Examples of such statements include,
but are not limited to, statements relating to (i) the potential
approval of TransCon PTH in the European Union; (ii) Ascendis’
ability to apply its platform technology to build a leading, fully
integrated, global biopharma company; and (iii) Ascendis’ use of
its TransCon technologies to create new and potentially
best-in-class therapies. Ascendis may not actually achieve the
plans, carry out the intentions or meet the expectations or
projections disclosed in the forward-looking statements and you
should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from
the plans, intentions, expectations and projections disclosed in
the forward-looking statements. Various important factors could
cause actual results or events to differ materially from the
forward-looking statements that Ascendis makes, including the
following: dependence on third party manufacturers, distributors
and service providers for Ascendis’ products and product
candidates; unforeseen safety or efficacy results in Ascendis’
development programs or on-market products; unforeseen expenses
related to commercialization of any approved Ascendis products;
unforeseen expenses related to Ascendis’ development programs;
unforeseen selling, general and administrative expenses, other
research and development expenses and Ascendis’ business generally;
delays in the development of its programs related to manufacturing,
regulatory requirements, speed of patient recruitment or other
unforeseen delays; Ascendis’ ability to obtain additional funding,
if needed, to support its business activities; the impact of
international economic, political, legal, compliance, social and
business factors, including inflation, the effects on its business
from the worldwide COVID-19 pandemic and ongoing conflicts such as
that in the region surrounding Ukraine and Russia. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to Ascendis’ business in
general, see Ascendis’ Annual Report on Form 20-F filed with the
U.S. Securities and Exchange Commission (SEC) on February 16, 2023
and Ascendis’ other future reports filed with, or submitted to, the
SEC. Forward-looking statements do not reflect the potential impact
of any future licensing, collaborations, acquisitions, mergers,
dispositions, joint ventures, or investments that Ascendis may
enter into or make. Ascendis does not assume any obligation to
update any forward-looking statements, except as required by
law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company
logo, and TransCon ® are trademarks owned by the Ascendis Pharma
group. © October 2023 Ascendis Pharma A/S.
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ir@ascendispharma.com |
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