COPENHAGEN, Denmark, Feb. 28, 2017 /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 acceptance of eight posters regarding its rare disease pipeline candidates at ENDO 2017, the annual meeting of the Endocrine Society taking place in Orlando, Florida, April 1-4, 2017.
"In addition to data supporting TransCon Growth Hormone, our long-acting product candidate in Phase 3, we will be presenting a broad package of preclinical pharmacology which supports the differentiated product profiles of TransCon PTH and TransCon CNP," said Jonathan Leff, M.D., Ascendis' Chief Medical Officer. "We look forward to advancing these product candidates into the clinic and remain on track for filing an IND or equivalent for TransCon PTH in the second quarter this year, and for TransCon CNP by year end."
Details of the ENDO 2017 presentations are summarized below. Abstracts of the presentations are also available on the ENDO 2017 website at:
https://endo.confex.com/endo/2017endo/meetingapp.cgi/SearchResults/0
TransCon Growth Hormone
Title: |
Design and Clinical Development of TransCon Growth Hormone for Growth Hormone Deficiency |
Date: |
Saturday, April 1, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
SAT 018 |
Title: |
User Driven Development of a New Device for Weekly Growth Hormone Administration in Pediatric Patients |
Date: |
Saturday, April 1, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
SAT 017 |
Title: |
Design of a Bracketed Dosing Regimen for the Administration of TransCon GH, a Once-Weekly Growth Hormone Product |
Date: |
Saturday, April 1, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
SAT 019 |
Title: |
Design and Rationale for the heiGHt Trial, a Phase 3 TransCon GH Study in Children with Growth Hormone Deficiency |
Date: |
Sunday, April 2, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
SUN 464 |
TransCon PTH
Title: |
TransCon PTH, a Sustained-Release PTH Analogue for the Treatment of Hypoparathyroidism – Proof-of-Principle in Monkeys and TPTx Rats |
Date: |
Saturday, April 1, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
LB SAT 46 (Late-Breaking Session) |
Title: |
Pharmacokinetics of TransCon PTH, a Sustained-Release PTH Prodrug for Hypoparathyroidism, in Rat and Cynomolgus Monkey |
Date: |
Saturday, April 1, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
SAT 355 |
TransCon CNP
Title: |
TransCon CNP, a Sustained-Release Prodrug of C-Type Natriuretic Peptide, Effects Positive Bone Growth in Young Cynomolgus Monkeys and in a Mouse Model of Achondroplasia |
Date: |
Saturday, April 1, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
LB SAT 03 (Late-Breaking Session) |
Title: |
TransCon CNP, a Sustained-Release C-Type Natriuretic Peptide Analogue, for the Treatment of Achondroplasia |
Date: |
Monday, April 3, 2017 |
Time: |
1:00 – 3:00 PM |
Poster: |
MON 331 |
About Ascendis Pharma A/S
Ascendis Pharma is applying the TransCon technology platform to build a leading rare disease commercial company. The company utilizes 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.
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.
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 file an IND or equivalent for TransCon PTH in the second quarter this year, and for TransCon CNP by year end, (ii) our ability to apply the TransCon technology platform to build a leading rare disease commercial company, and (iii) our expectations regarding our ability to create therapies with potential for best-in-class efficacy, safety and/or convenience. 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 Report on Form 6-K filed with the SEC on October 18, 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: |
Investor contact: |
Media contact: |
Scott T. Smith |
Patti Bank |
Ami Knoefler |
Chief Financial Officer |
Westwicke Partners |
SparkBioComm |
(650) 352-8389 |
(415) 513-1284 |
(650) 739-9952 |
SOURCE Ascendis Pharma A/S
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