Versartis completes Enrollment of Phase 3 trial of somavaratan (12.40) Amunix announced that Versartis (VSAR) has completed enrollment of a Phase 3 study of somavaratan (XTENylated recombinant growth hormone) in pediatric patients with growth hormone deficiency.
Somavaratan is a long-acting version of growth hormone created using Amunix's XTEN technology under license to Versartis. Somavaratan's twice-monthly dosing schedule in pediatric patients is the least frequent dosing interval in development for long-acting growth hormones. Versartis disclosed that 137 patients have now been enrolled in the VELOCITY trial that 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 expected in Q3 2017.