The VELOCITY Study Begins for Long-Acting Recombinant Human Growth Hormone in GHD Pediatric Patients
MENLO PARK, CA, USA I January 8, 2015 I Versartis, Inc. (VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced the initiation of its Phase 3 study of VRS-317 for semi-monthly dosing in children with growth hormone deficiency (GHD). This registration trial follows positive data from the Company’s completed Phase 1b/2a VERTICAL study and the ongoing long-term Extension Study.
“The initiation of our global Phase 3 study in pediatric GHD patients is a significant milestone in our goal of commercializing VRS-317,” said Jeffrey L. Cleland, PhD, Chief Executive Officer. “After 12 months of continuous dosing with VRS-317 in our Phase 1b/2a and Extension Study, we are confident in our trial design and look forward to furthering the development of our lead product candidate as a semi-monthly treatment. Our team has extensive knowledge and experience in bringing growth hormone therapies to market and we are diligently working towards commercializing VRS-317 for patients and families who suffer with the burden of daily dosing events.”
The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Study is a randomized, open-label, Phase 3 registration study being conducted in the United States, Western Europe and Canada. This study is expected to enroll up to 136 naive to treatment, pre-pubertal children with GHD and will include a 3:1 randomization of 3.5 mg/kg VRS-317 semi-monthly to daily rhGH at the highest approved dose on the labels of Genotropin(R) and Norditropin(R) 34 ug/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12 month height velocity. After completing the Phase 3 study, all patients will be offered the opportunity to continue treatment with VRS-317 in the ongoing pediatric Extension Study. The Company anticipates having six month interim results in mid-2016 and final data in early 2017.
About Versartis
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD). VRS-317 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, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD in June 2014 and began a global Phase 3 registration study in GHD children in January 2015. Further information on Versartis can be found at www.versartis.com.
SOURCE: Versartis
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The VELOCITY Study Begins for Long-Acting Recombinant Human Growth Hormone in GHD Pediatric Patients
MENLO PARK, CA, USA I January 8, 2015 I Versartis, Inc. (VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced the initiation of its Phase 3 study of VRS-317 for semi-monthly dosing in children with growth hormone deficiency (GHD). This registration trial follows positive data from the Company’s completed Phase 1b/2a VERTICAL study and the ongoing long-term Extension Study.
“The initiation of our global Phase 3 study in pediatric GHD patients is a significant milestone in our goal of commercializing VRS-317,” said Jeffrey L. Cleland, PhD, Chief Executive Officer. “After 12 months of continuous dosing with VRS-317 in our Phase 1b/2a and Extension Study, we are confident in our trial design and look forward to furthering the development of our lead product candidate as a semi-monthly treatment. Our team has extensive knowledge and experience in bringing growth hormone therapies to market and we are diligently working towards commercializing VRS-317 for patients and families who suffer with the burden of daily dosing events.”
The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Study is a randomized, open-label, Phase 3 registration study being conducted in the United States, Western Europe and Canada. This study is expected to enroll up to 136 naive to treatment, pre-pubertal children with GHD and will include a 3:1 randomization of 3.5 mg/kg VRS-317 semi-monthly to daily rhGH at the highest approved dose on the labels of Genotropin(R) and Norditropin(R) 34 ug/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12 month height velocity. After completing the Phase 3 study, all patients will be offered the opportunity to continue treatment with VRS-317 in the ongoing pediatric Extension Study. The Company anticipates having six month interim results in mid-2016 and final data in early 2017.
About Versartis
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD). VRS-317 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, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD in June 2014 and began a global Phase 3 registration study in GHD children in January 2015. Further information on Versartis can be found at www.versartis.com.
SOURCE: Versartis
Post Views: 30
