Ascendis Pharma A/S, a clinical stage biotechnology company that applies its innovative TransCon technology to address significant unmet medical needs, today announced that it has initiated a Phase 1 single ascending dose study of TransCon Treprostinil in healthy volunteers. TransCon Treprostinil is being developed to treat pulmonary arterial hypertension, a life-threatening orphan disease characterized by elevated blood pressure in the pulmonary arteries.
TransCon Treprostinil has been designed as an inert prodrug that enables a sustained release of unmodified treprostinil in circulation following a once-daily self-administered subcutaneous injection. TransCon Treprostinil is intended to produce a pharmacokinetic profile comparable to continuously infused prostacyclins, with the benefit of a more convenient route of administration, while avoiding the infusion site pain and risk of bloodstream infections associated with currently marketed infused prostacyclin therapies.
"The initiation of this Phase 1 study for our second wholly-owned clinical program is an important milestone for Ascendis," stated Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. "Our clinical stage pipeline is now comprised of long-acting TransCon prodrugs that incorporate both small molecules and proteins, demonstrating the broader potential of the TransCon technology platform."
The Phase 1 study is a single ascending dose study that will evaluate pharmacokinetic, injection tolerability, and safety parameters in a healthy volunteer population. Ascendis expects to report results from this study in mid-2015.
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