Ascendis Pharma A/S Announces Participation in ENDO Online 2020
Ascendis Pharma A/S (Nasdaq: ASND) presented findings from its rare disease endocrinology programs at ENDO Online 2020. The fliGHt Trial showed that patients can safely switch from daily somatropin to TransCon hGH, maintaining consistent efficacy. Interim data from the heiGHt Trial reaffirmed height advantages beyond one year of therapy. The company plans to submit marketing applications in the U.S. this quarter and in Europe by Q3. Additionally, promising data for TransCon PTH highlights its potential as a replacement therapy for hypoparathyroidism.
- Successful presentation of trial results at a major conference.
- Demonstrated safety and efficacy of TransCon hGH in switching from daily somatropin.
- Maintenance of height advantage in long-term subjects.
- Plans to submit marketing applications in the U.S. and Europe on schedule.
- Positive top-line data for TransCon PTH, indicating strong potential for hypoparathyroidism treatment.
- None.
COPENHAGEN, Denmark, June 08, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced presentations related to its rare disease endocrinology programs at ENDO Online 2020, the annual meeting of the Endocine Society, taking place June 8 - 22, 2020.
“The fliGHt Trial data presented at ENDO Online demonstrate that subjects taking daily somatropin can safely switch to TransCon hGH, our investigational long-acting prodrug that releases somatropin, with consistent and predictable efficacy,” said Jan Mikkelsen, Ascendis Pharma’s President and CEO. “Further, the interim data from heiGHt Trial subjects who continued in the enliGHten long-term extension trial demonstrated the maintenance of a height advantage in subjects initially treated with TransCon hGH beyond the first year of therapy. We remain on track to submit our marketing applications in the United States this quarter and in Europe in the third quarter.”
He continued, “Additionally, our recently-reported top-line PaTH Forward data for TransCon PTH, our long-acting prodrug of parathyroid hormone, demonstrated the ability of TransCon PTH to replace standard of care over a short, four-week fixed dose blinded period, highlighting its potential as a PTH hormone replacement therapy to treat hypoparathyroidism.”
ENDO Online 2020 Presentation Details
Oral Presentation | |
| Title | Date Time |
| Phase 3 fliGHt Trial: Experience of Switching from Daily Growth Hormone Therapy to Once-weekly TransCon hGH in Children with Growth Hormone Deficiency | Monday, June 8 8:00 a.m. (Pacific time) 11:00 a.m. (Eastern time) |
Abstracts | |
| Title | Reference |
| Maintenance of Favorable Treatment Effect of Once-Weekly TransCon hGH for Children with Growth Hormone Deficiency: Interim Analysis from the enliGHten Long-Term Extension Trial | Journal of the Endocrine Society, Volume 4, Issue Supplement_1, April-May 2020 |
| Design of the PaTH Forward Phase 2 Trial of TransCon PTH, a Long-acting PTH, in Patients with Hypoparathyroidism | Journal of the Endocrine Society, Volume 4, Issue Supplement_1, April-May 2020 |
If you are a healthcare provider who would like more information, please contact: medicalaffairs@ascendispharma.com.
About TransCon™ Technology
TransCon refers to “transient conjugation.” The proprietary TransCon platform is an innovative technology to create new therapies that are designed to potentially optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.
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 utilizes its TransCon™ technologies to create new and potentially best-in-class therapies.
Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.
Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, and in Palo Alto and Redwood City, California.
For more information, please visit www.ascendispharma.com.
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 our 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) our plans to submit our marketing applications in the United States this quarter and in Europe in the third quarter, (ii) our ability to apply our platform technology to build a leading, fully integrated biopharma company, (iii) our expectations regarding our ability to create potentially best-in-class therapies and (iv) our product pipeline. We 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 we make, including the following: unforeseen safety or efficacy results in our TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of 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; our ability to obtain additional funding, if needed, to support our business activities and the effects on our business of 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 our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC on April 3, 2020. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do 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 and TransCon are trademarks owned by the Ascendis Pharma group. ©June 2020 Ascendis Pharma A/S.
FAQ
What were the key findings from Ascendis Pharma's presentations at ENDO Online 2020?
When does Ascendis Pharma plan to submit its marketing applications for TransCon hGH?
What is the significance of the fliGHt Trial for TransCon hGH?
How does TransCon PTH relate to the treatment of hypoparathyroidism?
