BioCentury
ARTICLE | Clinical News

VRS-317: Additional Phase Ib/IIa data

August 11, 2014 7:00 AM UTC

Data from 64 pre-pubertal children with GHD who have not been treated with rhGH in the Phase IIa portion of the open-label, U.S. Phase Ib/IIa VERTICAL trial showed that VRS-317 led to an annualized 6-month height velocity, the primary endpoint, that was comparable to that of a historical control cohort of age-matched GHD children who received once-daily 33 Ug/kg rhGH - the highest approved dose of Norditropin somatropin and Genotropin somatropin. Specifically, annualized mean height velocities at 6 months were 7.6 cm/year for once-weekly 1.15 mg/kg VRS-317 vs. 8.4 cm/year for historical controls; 8.7 cm/year for semi-monthly 2.5 mg/kg VRS-317 vs. 8.3 cm/year for historical controls; and 7.9 cm/year for once-monthly 5 mg/kg VRS-317 vs. 8.3 cm/year for historical controls. Data were presented at the ICE/ENDO meeting in Chicago. Versartis said 60 patients have enrolled in a long-term extension trial of VRS-317. ...