Latest Clinical and Quality-of-Life Data for TransCon™ PTH (Palopegteriparatide)-Treated Adults with Chronic Hypoparathyroidism to Be Presented at ECE 2024
May 09 2024 - 8:30AM
Ascendis Pharma A/S (Nasdaq: ASND) today announced that new
TransCon PTH (palopegteriparatide) data supporting clinical and
quality-of-life benefits in adult patients with chronic
hypoparathyroidism will be presented at the European Congress of
Endocrinology being held May 11-14, 2024, in Stockholm.
Topics include an oral presentation of new 2-year results from a
post-hoc analysis of the Phase 3 PaTHway Trial demonstrating
sustained improvements in kidney function in adults with chronic
hypoparathyroidism treated with TransCon PTH, as well as a
symposium presentation on health and quality-of-life improvements
in patients switching from rhPTH(1-84) to TransCon PTH as part of a
compassionate use program.
“We are pleased to partner with leading experts in endocrinology
to present this new, groundbreaking data showing the health and
quality-of-life benefits of initiating or switching to TransCon PTH
treatment,” said Aimee Shu, M.D., Ascendis Pharma’s Senior Vice
President of Clinical Development, Endocrine Medical Sciences.
The full schedule of Ascendis presentations during ECE 2024
follow:
Sunday, May 122:50 pm (2:40 pm session)Rooms A2-A3 |
Oral PresentationSustained Improvement in Renal Function
with Palopegteriparatide in Adults with Chronic Hypoparathyroidism:
2-Year Results from the Phase 3 PaTHway TrialDr. Peter
Schwarz |
Monday, May 1312:40 – 1:55 pmRoom A7 |
SymposiumReplacing What’s Missing in Chronic
Hypoparathyroidism – Treatment with Palopegteriparatide
- Hypoparathyroidism, Current
Management and Palopegteriparatide Dr. Andrea Palermo
- Bone Metabolism & New
2-Year Renal Data Dr. Peter Schwarz
- Patient-Reported Outcomes
& Initial Data from Compassionate Use of
PalopegteriparatideDr. Heide Siggelkow
|
About HypoparathyroidismHypoparathyroidism is
an endocrine disease caused by insufficient levels of parathyroid
hormone (PTH), the primary regulator of calcium and phosphate
balance in the body, acting directly on bone and kidneys and
indirectly on the intestines. Individuals with hypoparathyroidism
may experience a range of severe and potentially life-threatening
short-term and long-term complications, including neuromuscular
irritability, renal complications, extra-skeletal calcifications,
and cognitive impairment. Post-surgical hypoparathyroidism accounts
for the majority of cases (70-80%), while other etiologies include
autoimmune and idiopathic causes.
About TransCon PTHTransCon PTH
(palopegteriparatide) is a prodrug of parathyroid hormone (PTH
1-34) administered once daily, designed to provide parathyroid
hormone levels within the normal physiological range across the
24-hour dosing period. TransCon PTH was granted marketing
authorization under the brand name YORVIPATH® by the European
Commission (EC) and the European Economic Area
in November 2023 and by the United Kingdom’s Medicines
& Healthcare Products Regulatory Agency (MHRA) in Great Britain
in April 2024 as a PTH replacement therapy indicated for the
treatment of adults with chronic hypoparathyroidism. In the
United States, the U.S. Food & Drug
Administration (FDA) has set a PDUFA date of May 14,
2024 to complete their review of Ascendis Pharma’s New Drug
Application for TransCon PTH for adults with chronic
hypoparathyroidism. TransCon PTH is also in development
in Japan through Teijin Ltd. and in
China through VISEN Pharmaceuticals.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform 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, Ascendis uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Europe and the United States. 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) TransCon PTH’s
PDUFA date of May 14, 2024, (ii) Ascendis’ ability to apply its
TransCon technology platform to build a leading, fully integrated
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. 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 7, 2024 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, TransCon, and YORVIPATH® are trademarks owned by the Ascendis
Pharma group. © May 2024 Ascendis Pharma A/S.
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Media Contact: |
Tim Lee |
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Melinda Baker |
Ascendis Pharma |
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Ascendis Pharma |
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+1 (650) 709-8875 |
tle@ascendispharma.com |
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media@ascendispharma.com |
ir@ascendispharma.com |
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Patti Bank |
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ICR Westwicke |
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+1 (415) 513-1284 |
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patti.bank@westwicke.com |
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