Versartis (VSAR) Completes Phase 3 VELOCITY Trial Enrollment

August 22, 2016 8:33 AM EDT

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Versartis, Inc. (Nasdaq: VSAR) 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.”

"We are grateful to the patients and their families as well as the investigators who are taking part in VELOCITY. We look forward to completing this Phase 3 trial and reporting top-line results around this time next year,” said Jay Shepard, Versartis' Chief Executive Officer. “In the meantime, the Versartis team is fully focused on advancing the somavaratan development program in North America, Europe and Japan and initiating our collaboration with Teijin, our Japanese partner for commercialization.”

The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Trial is a randomized, open-label, Phase 3 registration trial in the United States, Europe and Canada. This study enrolled naïve to treatment, pre-pubertal children with GHD who were randomized 3:1 to 3.5 mg/kg of somavaratan twice-monthly or daily rhGH at 34 µg/kg/day, the highest approved GHD dose on the labels of Genotropin® and Norditropin®.

As with patients who completed the prior Phase 2 trial of somavaratan in pediatric GHD, patients completing the Phase 3 VELOCITY trial will have the opportunity to transition to an ongoing, open-label, long-term safety study named VISTA (Versartis Long-Term Safety Study of Somavaratan). Versartis reported confirmatory two-year safety and efficacy data from Phase 2 extension study patients during the Endocrine Society Annual Meeting in Q2 2016.

Somavaratan’s twice-monthly dosing schedule is the least frequent dosing interval in development for long-acting growth hormones. Somavaratan also has the potential to be the first long-acting growth hormone product to enter the market for pediatric GHD, with its clinical development program being the furthest advanced. In addition to the Phase 3 VELOCITY trial, the J14VR5 trial is underway in Japan in pediatric GHD and is expected to transition from Phase 2 to Phase 3 by the end of 2016. In adult GHD, top-line results from the Phase 2 VITAL trial in the U.S., Europe, and Australia are expected during the second half of 2016. Versartis retains global rights to somavaratan outside Japan, where it has a strategic alliance with Teijin Limited for commercialization and future development.

Analyst and Investor Symposium

Versartis will also host a breakfast symposium for institutional investors and equity research analysts on Thursday, September 15, 2016, from 8:00-10:30 am in New York City. The event will feature presentations from Dr. Alan Rogol and two additional leading experts in growth hormone deficiency as well as the Versartis management team. Details regarding the event webcast will be announced prior to the event. Analysts and investors may email for more information or to RSVP.

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