New 3-Year Skeletal Dynamics Data for Adults with Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide) Presented at ASBMR 2024

COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- 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/S

Ascendis 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.