COPENHAGEN, Denmark, April 4, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biotechnology company that applies its innovative TransCon technology to address significant unmet medical needs, today announced multiple TransCon Growth Hormone presentations made during the Endocrine Society's 98th Annual Meeting & Expo (ENDO 2016), held at the Boston Convention and Exhibit Center April 1-4, 2016. The data presentations included an oral presentation of the final once-weekly TransCon Growth Hormone Phase 2 pediatric trial results along with two supporting poster presentations. Following the positive results observed with TransCon Growth Hormone in its Phase 2 pediatric trial, Ascendis expects to begin its global Phase 3 heiGHt trial in growth hormone deficient (GHD) children in mid-2016.
Prof. Pierre Chatelain, M.D., Coordinating Investigator of the Phase 2 pediatric trial, and former Chairman of the College of Pediatrics at the Université Claude Bernard Lyon 1, delivered a presentation during the Pediatric Endocrinology Clinical/Translational Oral Session at the conference titled, "A Phase 2 Six-Month Safety and Efficacy Study of TransCon Growth Hormone Compared to Daily hGH in Children with Growth Hormone Deficiency (GHD)".
Prof. Chatelain commented, "TransCon Growth Hormone's unique design makes it the only long-acting growth hormone in development that provides a sustained-release of native recombinant growth hormone to the patient. The positive Phase 2 trial results presented at ENDO 2016 confirmed the attractive profile of once-weekly TransCon Growth Hormone, which had previously demonstrated a comparable efficacy, safety, tolerability, and immunogenic profile to the active daily hGH control, Genotropin®."
Additionally, Ascendis made two poster presentations during the conference, which are currently available on its corporate website, www.ascendispharma.com/product-pipeline/publications:
- "Pediatric Phase 2 Data Demonstrate that TransCon hGH has an Anti-hGH Immunogenic Profile that is Comparable to Daily hGH", (Gilfoyle, et al.)
- "Pharmacokinetic Model Guided Design of TransCon Growth Hormone, to Ensure Unmodified Growth Hormone Levels Comparable to Daily Growth Hormone", (Sprogøe, et al.)
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology to develop an internal pipeline of therapeutics to address unmet medical needs in rare disease indications carrying billion-dollar potential. The Ascendis Pharma internal pipeline consists of existing parent drugs with known pharmacology, and features TransCon Growth Hormone, a wholly-owned program that has completed Phase 2 studies in adults and children with growth hormone deficiency. The global pediatric Phase 3 heiGHt trial of TransCon Growth Hormone is expected to begin in mid-2016.
Additionally, Ascendis Pharma has formed collaborations with Sanofi in diabetes and Genentech in the field of ophthalmology, which are focused on developing leading products in large markets of strategic importance to these partners.
The TransCon technology combines the benefits of prodrug and sustained-release technologies, and is the key driver of Ascendis Pharma's mission to develop a pipeline of therapeutics with best-in-class profiles. The TransCon technology can be applied to a broad range of drug therapies, including proteins, peptides and small molecules, to create prodrugs that provide for the predictable and sustained-release of an unmodified parent drug.
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 our product pipeline, including our plans to initiate our global Phase 3 heiGHt trial in GHD children in mid-2016. 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 lead development program TransCon Growth Hormone or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone 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 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, 2014 and our Report on Form 6-K which we submitted with the SEC on November 16, 2015. 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.
Martin Auster, M.D.
Chief Business Officer
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SOURCE Ascendis Pharma A/S