Ascendis Pharma A/S Announces Multiple TransCon Growth Hormone Presentations at the European Society of Paediatric Endocrinology Annual Meeting
- Phase 2 data support potential best-in-class profile for once-weekly TransCon Growth Hormone -
COPENHAGEN, Denmark, Sept. 9, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address significant unmet medical needs in rare diseases, today announced presentation of four posters at ESPE 2016, the 55th annual meeting of the European Society of Paediatric Endocrinology in Paris on September 10-12, 2016.
"These additional presentations from our Phase 2 program demonstrate the attractive profile of our once-weekly TransCon Growth Hormone product candidate and its comparable safety, efficacy and tolerability to a daily growth hormone therapy," said Jonathan Leff, M.D., Senior Vice President and Chief Medical Officer at Ascendis. "The strong results of our Phase 2 data also support the recent initiation of our Phase 3 heiGHt Trial, which is now underway to evaluate TransCon Growth Hormone in pediatric patients with growth hormone deficiency (GHD)."
Details of the ESPE 2016 presentations, which will be posted on the Publications page in the Pipeline section of the Ascendis Pharma website (http://ascendispharma.com/product-pipeline/publications/), include:
| Abstract # 656 |
|
| Title: |
Pediatric Phase 2 Data Demonstrate that TransCon hGH has an Anti-hGH Immunogenic Profile Comparable to Daily hGH |
| Presenting Author: |
David Gilfoyle, Ph.D., Ascendis Pharma A/S |
| Date: |
September 10, 2016 |
| Time: |
12:45 p.m. - 1:45 p.m. (Central European Time/CET) |
| Abstract # 673 |
|
| Title: |
Pharmacokinetic Modelling Predicts Native hGH Levels Following Administration of a Sustained-Release Prodrug, TransCon hGH, to Children with GHD |
| Presenting Author: |
Kennett Sprogøe, Ph.D., Ascendis Pharma A/S |
| Date: |
September 12, 2016 (also Oral Presentation) |
| Time: |
9:15 a.m. - 10:45 a.m. (Central European Time/CET) |
| Abstract # 744 |
|
| Title: |
A Six-Month Safety and Efficacy Study of TransCon hGH Compared to Daily hGH in Pre-Pubertal Children with Growth Hormone Deficiency (GHD) |
| Presenting Author: |
Professor Pierre Chatelain, M.D., Coordinating Investigator of the Phase 2 pediatric study, former Chairman of the College of Pediatrics at the Université Claude Bernard Lyon 1, and Professor Emeritus of Pediatrics |
| Date: |
September 12, 2016 (also Oral Presentation) |
| Time: |
9:15 a.m. - 10:45 a.m. (Central European Time/CET) |
| Abstract # 255 |
|
| Title: |
Design and Clinical Development of TransCon Growth Hormone for Growth Hormone Deficiency |
| Presenting Author: |
Michael Beckert, M.D., Ascendis Pharma A/S |
| Date: |
September 12, 2016 |
| Time: |
1:45 p.m. - 2:45 p.m. (Central European Time/CET) |
About Ascendis Pharma A/S
Ascendis Pharma is a biopharmaceutical company utilizing its innovative TransCon technology to address significant unmet medical needs in rare diseases by improving clinically-validated parent drugs and creating therapies with potential for best-in-class efficacy, safety and/or convenience. The company is applying the TransCon technology platform to build a leading rare disease commercial company, while also leveraging it across a broad range of therapies through collaborations.
Ascendis Pharma has a wholly-owned pipeline of rare disease endocrinology programs, including once-weekly TransCon Growth Hormone, which is currently being evaluated in the Phase 3 heiGHt Trial for children with growth hormone deficiency (GHD), TransCon PTH, a long-acting prodrug of parathyroid hormone for hypoparathyroidism, and TransCon CNP, a long-acting prodrug of C-Type Natriuretic Peptide for achondroplasia. Additionally, Ascendis Pharma has multi-product collaborations with Sanofi in diabetes and Genentech in the field of ophthalmology, which are focused on using the TransCon technology to develop leading products.
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 product pipeline, (ii) our ability to apply the TransCon technology platform to build a leading rare disease commercial company and to generally leverage our platform across a broad range of therapies through our collaborations, (iii) our expectations regarding our once-weekly TransCon Growth Hormone product candidate's safety, efficacy and tolerability profile and (iv) our belief that our Phase 2 data supports the recent initiation of our Phase 3 heiGHt Trial. 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 Growth Hormone, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone, 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 Growth Hormone, 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; and our ability to obtain additional funding, if needed, to support our business activities. 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 for the year ended December 31, 2015, which we filed with the SEC on April 15, 2016. 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.
Internal contact:
Scott T. Smith
Chief Financial Officer
(650) 352-8389
ir@ascendispharma.com
Investor contact:
Patti Bank
Westwicke Partners
(415) 513-1284
patti.bank@westwicke.com
Media contact:
Ami Knoefler
SparkBioComm
(650) 739-9952
ami@sparkbiocomm.com
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