New data highlights include:
- Phase 3 open-label extension study data for growth hormone-deficient children treated for 2.5 years with TransConTM hGH
- Initial findings from research on comorbidities associated with adult growth hormone deficiency
COPENHAGEN, Denmark, May 01, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S ( ASND) today announced that the company will present clinical and research outcomes and host informational booths and events at four medical meetings during May. Topics will include new open-label extension data for children with growth hormone deficiency treated with TransCon hGH for 2.5 years; research findings showing comorbidities associated with adult growth hormone deficiency; and presentations of TransCon PTH Phase 2 patient-reported health, quality-of-life, and Week 84 data in adult hypoparathyroidism. Meetings in the United States will also showcase SKYTROFA® (lonapegsomatropin-tcgd), the Company’s FDA-approved once-weekly treatment for pediatric growth hormone deficiency.
“The flow of data that begins today at the PES annual meeting signifies the growing strength and breadth of our endocrinology rare disease portfolio,” said Dana Pizzuti, M.D., Senior Vice President and Chief Medical Officer at Ascendis Pharma. “We are excited to demonstrate the many areas where we are applying TransCon technology to make a meaningful difference for patients and look forward to interacting with a broad range of endocrinology physicians, nurses, and healthcare professionals virtually and in person in the weeks ahead.”
Ascendis Pharma’s data and research presentations during the month of May are listed below. Registered attendees can find out more details at each event’s website.
|April 28 - May 1 |
Lonapegsomatropin in Children with Growth Hormone Deficiency: Efficacy & Safety After 2.5 years in the enliGHtenTrial
An analysis of the subset of participants who completed the trial, with information on difference between last visit height and target height, and difference between height SDS at last visit and average parental height SDS
Virtual event; recorded, with Live Q&A
Sunday, May 1, 2022 from 2:00 – 2:30pm ET
|May 7-10 |
Sustained Efficacy and Safety with TransCon PTH for Adults with Hypoparathyroidism Through Week 84 in the Phase 2 PaTH Forward Trial
An evaluation of data at Week 84 in the PaTH Forward trial of TransCon PTH in adults with hypoparathyroidism showed 93% of participants achieving continued independence from conventional therapy with maintenance of mean serum calcium (sCa) and 24-hour urinary calcium (uCa) in the normal range.
Date & time to be announced
Pediatric Endocrinology Nursing Society
Bonita Springs, FL
Continued Efficacy and Safety after 2.5 Years of Treatment with Lonapegsomatropin (TransCon hGH) in Children with Growth Hormone Deficiency in the enliGHtentrial
Data from Week 130 of the enliGHten trial reporting consistent long-term safety and sustained growth in pediatric growth hormone-deficient patients treated for 2.5 years with TransCon hGH. Also includes outcomes from auto-injector device usability questionnaire.
Date and time to be announced.
European Society of Endocrinology
|Oral Presentation #1|
Health Related Quality of Life in Adults with Hypoparathyroidism in the Phase 2 Path Forward Trial of TransCon PTH
An analysis of patient-reported health and quality-of-life impacts from the
SF-36®and Hypoparathyroidism Patient Experience Scale (HPES) – Symptom tools during the Phase 2 Path Forward Study of TransCon PTH in adult hypoparathyroidism.
Oral Presentation #2
Prevalence of Comorbidities in a U.S. Adult Population with Growth Hormone Deficiency
An analysis of the comorbidity burden in adult patients diagnosed with growth hormone deficiency (GHD) compared to non-GHD controls.
Recorded, with Live Q&A
Dates and times to be announced.
About Ascendis Pharma A/S
Ascendis 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 Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit www.ascendispharma.com to learn more.
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 platform technology 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 and distributors to supply TransCon hGH, the SKYTROFA® Auto-Injector and other study drug for commercial sales in the U.S. and clinical studies; unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to commercialization of lonapegsomatropin-tcgd in the U.S., the co-pay program, and the further development of TransCon hGH, expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis’ ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. 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 March 2, 2022 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 SKYTROFA are trademarks owned by the Ascendis Pharma Group. © May 2022 Ascendis Pharma A/S.
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