Date: 2015-09-10
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Versartis (USA - CA)
Product: somavaratan (VRS-317)
Action
mechanism: peptide/growth hormone derivative. Somavaratan (VRS-317) is a novel, long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency (GHD). It is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes.
Disease: adult growth hormone deficiency
Therapeutic area: Endocrinological diseases - Hormonal diseases
Country: USA
Trial
details: The adult Phase 2 VITAL trial is a dose-finding safety study to evaluate a monthly somavaratan dosing regimen in adults with GHD. The study is an open-label, international, multicenter study with somavaratan treatment for five months. This treatment period will include monthly dose titrations until a subject\'s mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on age, gender and the use of oral estrogens.(NCT02526420)
Latest
news: * On September 10, 2015, Versartis, an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD),announced the initiation of its Phase 2 trial, Versartis International Trial in Adults with Long-Acting Growth Hormone (VITAL), of somavaratan in adults with GHD. Versatis has also initiated a global Phase 3 registration trial, VELOCITY, in GHD children in January 2015. In addition, the Company initiated a Phase 2/3 trial in Japan for children with GHD in April 2015.
