2022-05-01 | NDAQ:ASND | Press release

New data highlights include:

– Data from Phase 3 open-label extension study for children with growth hormone deficiency treated for 2.5 years with TransConMT hGH

– First results of research on comorbidities associated with growth hormone deficiency in adults

COPENHAGEN, Denmark, May 01, 2022 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) announced today that the company will present clinical and research results and host information booths and events at four medical meetings in 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 growth hormone deficiency in adults; and presentations of health, quality of life, and week 84 data reported by TransCon PTH Phase 2 patients in adult hypoparathyroidism. Meetings in the United States will also feature SKYTROFA® (lonapegsomatropin-tcgd), the company’s FDA-approved once-weekly treatment for pediatric growth hormone deficiency.

“The stream of data beginning today at the PES annual meeting signifies the growing strength and breadth of our rare disease portfolio in endocrinology,” said Dana Pizzuti, MD, senior vice president and chief medical officer. at Ascendis Pharma. “We are excited to demonstrate the many areas in which we are applying TransCon technology to make a meaningful difference for patients and we look forward to interacting with a wide range of physicians, nurses and healthcare professionals. health in endocrinology virtually and in person in the coming weeks.”

Ascendis Pharma’s data and research presentations during the month of May are listed below. Registered attendees can find more details on each event’s website.

April 28 – May 1

PES 2022

Pediatric endocrinology



Oral presentation

Lonapegsomatropin in children with growth hormone deficiency: efficacy and safety After 2.5 years in the illuminateTrial

An analysis of the subset of participants who completed the trial, with information on the difference between height at last visit and target height, and the difference between SDS height at last visit and mean height of SDS parents

Virtual event; recorded, with live Q&A

Sunday May 1, 2022​ 2:00 p.m. to 2:30 p.m. ET

May 7-10

ECTS 2022

calcified european

Tissue Company

Helsinki, Finland

Oral presentation

Efficacy and Safety Sustained with TransCon PTH for Adults with Hypoparathyroidism Through Week 84 in the Phase 2 PaTH Forward Trial

An evaluation of week 84 data from the PaTH Forward trial of TransCon PTH in adults with hypoparathyroidism showed that 93% of participants achieved continued independence from conventional therapy with maintenance of mean serum calcium (sCa ) and 24-hour urinary calcium (uCa). normal range.

Date and time to be specified

May 18-21

PENS 2022

Pediatric Endocrinology Nursing Society

Bonita Springs, Florida

Oral presentation

Continued efficacy and safety after 2.5 years of treatment with lonapegsomatropin (TransCon hGH) in children with growth hormone deficiency in the illuminatetrial

Data from week 130 of the enliGHten trial showing consistent long-term safety and sustained growth in pediatric growth hormone deficient patients treated for 2.5 years with TransCon hGH. Also includes results from the Auto-Injector Usability Questionnaire.

Date and time to be specified.

May 21-24

EEC 2022

European Society of Endocrinology

Milan, Italy

& Virtual

Oral presentation #1

Health-Related Quality of Life in Adults with Hypoparathyroidism in the TransCon PTH Phase 2 Trial

An analysis of the impacts on health and quality of life declared by patients

SF-36®and Hypoparathyroidism Patient Experience Scale (HPES) – Symptom Tools in the Phase 2 TransCon PTH Study in Adult Hypoparathyroidism.

Oral presentation #2

Prevalence of comorbidities in an American adult population with growth hormone deficiency

An analysis of comorbidity burden in adult patients diagnosed with growth hormone deficiency (GHD) compared with non-GHD controls.

Recorded, with live Q&A

Dates and times to be specified.

About Ascendis Pharma A/S

Ascendis Pharma applies its innovative platform technology to create a leading, fully integrated biopharmaceutical company focused on meaningfully improving patients’ lives. Guided by its core values ​​of patients, science and passion, the company uses its TransCon technologies to create potentially best-in-class new therapies. Ascendis is headquartered in Copenhagen, Denmark, with additional facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, CA; and Princeton, New Jersey. Please visit www.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 fact, included in this press release regarding Ascendis’ management’s future operations, plans and objectives are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ ability to apply its technology platform to create a leading fully integrated biopharmaceutical company, and (ii) Ascendis’ using its TransCon technologies to create new, potentially best-in-class therapies. Ascendis may not actually achieve the plans, achieve the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on such 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 Ascendis’ forward-looking statements, including the following: reliance on third-party manufacturers and distributors to supply TransCon hGH, SKYTROFA® Auto-injector and other study drug for U.S. commercial sales and clinical studies; unexpected safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unanticipated expenses related to the commercialization of lonapegsomatropin-tcgd in the United States, the co-payment program and 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 in general; 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 enrollment or other unforeseen delays ; reliance on third-party manufacturers to supply study drug for planned clinical studies; Ascendis’ ability to obtain additional financing, if needed, to support its business operations and the effects on its business of the global COVID-19 pandemic. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks relating to Ascendis’ business generally, see Ascendis’ Annual Report on Form 20-F filed with the United States Securities and Exchange Commission (SEC) on March 2, 2022 and Ascendis’ other future reports filed or submitted with the SEC. Forward-looking statements do not reflect the potential impact of any future licenses, collaborations, acquisitions, mergers, divestitures, joint ventures or investments that Ascendis may enter into or make. Ascendis undertakes no obligation to update forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon and SKYTROFA are registered trademarks belonging to the Ascendis Pharma group. © May 2022 Ascendis Pharma A/S.

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