New 3-Year Skeletal Dynamics Data for Adults with Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide) Presented at ASBMR 2024
September 30 2024 - 8:30AM
Ascendis Pharma A/S (Nasdaq: ASND) shared 3-year results from the
Company’s ongoing Phase 2 PaTH Forward Trial of 57 adults with
hypoparathyroidism showing that long-term treatment with TransCon™
PTH (palopegteriparatide; marketed as YORVIPATH®) through Week 162
drove bone remodeling into the normal range. Deficiency of
parathyroid hormone is associated with low rates of bone
remodeling, accumulation of overly mature bone, and
higher-than-average bone mineral density that may correspond with
poorer overall bone quality compared to that seen in the general
population.1,2,3,4 In contrast, these results suggest that
long-term palopegteriparatide treatment promotes attainment of
skeletal health parameters in line with those expected with states
of parathyroid sufficiency.
TransCon PTH is a prodrug of parathyroid hormone (PTH [1-34]),
administered once daily, designed to provide continuous exposure to
released PTH over the 24-hour dosing period.
Lead author Mishaela Rubin, M.D., Associate Professor of
Medicine at Columbia University and an expert at the forefront of
characterizing the dynamic and structural abnormalities of bone in
hypoparathyroidism, shared the results in an oral presentation
during ASBMR 2024, the annual meeting of the American Society for
Bone & Mineral Research held in Toronto September 27-30.
Additional information associated with Dr. Rubin’s presentation,
titled Palopegteriparatide Improves Skeletal Dynamics in Adults
with Chronic Hypoparathyroidism: 3 Year Results from the Phase 2
PaTH Forward Trial (#1091), is available to ASBMR members and
registered attendees at https://asbmr.org.
About
Hypoparathyroidism Hypoparathyroidism 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
intestine. 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 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) Ascendis’
ability to apply its TransCon technology platform to build a
leading, fully integrated biopharma company and (ii) 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’ prospectus
supplement filed on September 20, 2024 and Ascendis’ current and
future reports filed with, or submitted to, the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form 20-F
filed with the SEC on February 7, 2024. 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. © September 2024 Ascendis Pharma A/S.
1. Rubin MR, et al. J Bone Miner Res 2008;23(12):2018-24. 2.
Rubin, MR, et al. J Bone Miner Res 2018;33(11):1931-9. 3. Misof BM,
et al. J Bone Miner Res 2016;31(1):180-9. 4. Cianferotti L, et al.
J Endocrinol Invest 2023;46(7):1283-1304.
Investor Contacts:Tim LeeAscendis Pharma+1 (650)
374-6343tle@ascendispharma.comir@ascendispharma.com |
Media
Contact:Melinda BakerAscendis Pharma+1 (650)
709-8875media@ascendispharma.com |
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Patti BankICR Westwicke+1 (415)
513-1284patti.bank@westwicke.com |
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