Source: Versartis, Inc. & reported by http://globenewswire.com/
MENLO PARK, Calif., Aug. 22, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ: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 completion of enrollment in the Phase 3 VELOCITY trial of somavaratan in pediatric GHD. With 137 patients enrolled, the trial is powered at >90% to demonstrate non-inferiority of somavaratan compared to daily rhGH. Patients will be followed for the primary trial endpoint of height velocity at 12 months, as well as safety and pharmacodynamic secondary endpoints. Top-line results are anticipated in Q3 2017.
“For more than three decades, recombinant human growth hormone has been effective to treat children, adolescents and adults with growth hormone deficiency, but the daily injection schedule is inconvenient and can be painful or distressing for children and their caregivers. These issues may also lead to patient non-compliance and thus, reduced efficacy,” said Alan D. Rogol, MD, PhD, an endocrinologist and Professor Emeritus at the University of Virginia School of Medicine. “Somavaratan may offer the least frequent dosing schedule with twice-monthly dosing, and with the Phase 3 VELOCITY trial now fully enrolled, it may be the first of the long-acting growth hormone preparations currently in development to become available for children with GHD.”
Read more: http://globenewswire.com/news-release/2016/08/22/865861/0/en/Versartis-Announces-Completion-of-Enrollment-in-Phase-3-VELOCITY-Trial-of-Somavaratan-in-Pediatric-GHD.html