Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biotechnology company that applies its TransCon technology to address significant unmet medical needs, announced today that its Phase 1 single ascending dose study of TransCon Treprostinil produced dose-dependent increases in plasma treprostinil levels in-line with expectations. However, treprostinil-related injection-site tolerability issues did not meet the criteria defined in the target product profile. Ascendis now intends to conduct additional research on new product formulations of TransCon Treprostinil and plans to resume clinical development when product improvements to mitigate current limitations have been addressed.
Jan Mikkelsen, Chief Executive Officer of Ascendis, stated "While we are pleased with the pharmacokinetic results observed in this study, and believe they affirm the potential of our TransCon technology, TransCon Treprostinil did not reproduce the tolerability profile observed in preclinical studies." Mr. Mikkelsen continued, "As we look forward to the remainder of 2015, we plan to finalize and report topline data from our Phase 2 pediatric study of TransCon Growth Hormone by mid-year and prepare for the initiation of our Phase 3 pediatric study in mid-2016. We will also continue to develop our internal pipeline of therapeutics for orphan diseases."
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