Source: Ascendis Pharma & reported by http://www.prnewswire.com/
COPENHAGEN, Denmark, Aug. 11, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biopharmaceutical company that applies its innovative TransCon technology to address significant unmet medical needs, today announced the initiation of the global Phase 3 TransCon Growth Hormone heiGHt Trial in children with growth hormone deficiency (GHD). The heiGHt Trial initiation follows End-of-Phase 2 discussions with the U.S. Food and Drug Administration (FDA), as well as various discussions with regulatory agencies worldwide.
"The Phase 3 heiGHt Trial initiation marks a major milestone for Ascendis and our TransCon Growth Hormone program as we move into the next stage of development," said Jonathan A. Leff, M.D., Senior Vice President and Chief Medical Officer at Ascendis. "This pivotal trial mirrors the design of our Phase 2 study in pediatric GHD that demonstrated comparable safety, efficacy, and tolerability of once-weekly TransCon Growth Hormone to a daily growth hormone therapy. This global trial is designed to support planned regulatory applications worldwide, including in the United States and Europe."
Dr. Leff continued, "The Phase 2 data for our once-weekly sustained-release TransCon Growth Hormone demonstrated the strong efficacy and favorable safety, tolerability, and convenience profile of our product candidate. As the only long-acting growth hormone that provides the same mode of action as daily growth hormone, we believe TransCon Growth Hormone can become a best-in-class option for physicians and patients to address the ongoing unmet need for an effective and convenient long-acting growth hormone therapy."
Read more: http://www.prnewswire.com/news-releases/ascendis-pharma-as-initiates-phase-3-registration-trial-for-transcon-growth-hormone-in-children-with-growth-hormone-deficiency-300312262.html