MENLO PARK, CA, USA I September 10, 2015 I Versartis, Inc. (VSAR), 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), today 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.
Jay Shepard, Chief Executive Officer, commented, “The initiation of our Phase 2 VITAL trial in adult patients is another significant milestone for Versartis as we work to expand the potential market for somavaratan. The adult population of patients with growth hormone deficiency is often overlooked and we believe that our long-acting rhGH product can have a significant impact on the treatment of adult GHD. With once-monthly dosing, we would have the ability to provide patients a less burdensome option than the current standard of care, and would have the impetus to raise awareness of GHD in the adult population and grow the market opportunity.”
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.
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency (GHD). Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, twice-monthly and monthly dosing regimens of somavaratan in children with GHD in June 2014 and 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 and a Phase 2 trial, VITAL, evaluating monthly dosing for adults with GHD in September 2015. Additional information on Versartis clinical trials can be found at www.versartistrials.com. Further information on Versartis can be found at www.versartis.com.
SOURCE: Versartis
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MENLO PARK, CA, USA I September 10, 2015 I Versartis, Inc. (VSAR), 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), today 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.
Jay Shepard, Chief Executive Officer, commented, “The initiation of our Phase 2 VITAL trial in adult patients is another significant milestone for Versartis as we work to expand the potential market for somavaratan. The adult population of patients with growth hormone deficiency is often overlooked and we believe that our long-acting rhGH product can have a significant impact on the treatment of adult GHD. With once-monthly dosing, we would have the ability to provide patients a less burdensome option than the current standard of care, and would have the impetus to raise awareness of GHD in the adult population and grow the market opportunity.”
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.
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency (GHD). Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, twice-monthly and monthly dosing regimens of somavaratan in children with GHD in June 2014 and 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 and a Phase 2 trial, VITAL, evaluating monthly dosing for adults with GHD in September 2015. Additional information on Versartis clinical trials can be found at www.versartistrials.com. Further information on Versartis can be found at www.versartis.com.
SOURCE: Versartis
Post Views: 112
