Versartis Announces Phase 3 VELOCITY Trial of Somavaratan in Pediatric Growth Hormone Deficiency Did Not Meet Primary Endpoin...
21 September 2017 - 10:30PM
Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused
biopharmaceutical company that is developing somavaratan, a novel,
long-acting form of recombinant human growth hormone (rhGH) for
growth hormone deficiency (GHD), today announced that the VELOCITY
Phase 3 clinical trial of somavaratan in pediatric growth hormone
deficiency (GHD) did not meet its primary endpoint of
non-inferiority.
Non-inferiority versus daily growth hormone was not demonstrated
in the intent to treat (ITT) population for the primary efficacy
variable, height velocity (HV) at 12 months. The 12-month HV for
ITT patients receiving somavaratan twice monthly was 9.44 cm,
versus 10.70 cm for those receiving Genotropin® 1 daily.
Non-inferiority was defined as the lower bound of the two-sided 95%
confidence interval of the difference between somavaratan and
Genotropin HV greater than or equal to -2.0 cm/year. In the ITT
study population the lower bound of this confidence interval was
-2.3 cm/year.
In the per protocol population (PP), non-inferiority was
demonstrated. The 12-month HV for PP patients receiving somavaratan
twice monthly was 9.71 cm, versus 10.63 cm for those receiving
Genotropin daily.
Somavaratan was well tolerated with treatment discontinuation
rate lower than for the Genotropin arm. No new emergent safety
signals were observed.
“We are very surprised and disappointed to learn the outcome of
the VELOCITY trial. Somavaratan showed height velocity in the range
we had hoped, but it was not sufficient to demonstrate
non-inferiority in this trial,” stated Jay Shepard, President and
CEO of Versartis, Inc. “We have done an initial analysis of the
top-line data and are continuing to thoroughly review the results
to gain greater insight into the trial outcome. We plan to provide
a corporate update later this year. I would like to thank the
investigators, pediatric GHD patients and families that
participated in the VELOCITY trial.”
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical
company initially developing somavaratan, a novel, long-acting form
of recombinant human growth hormone in late-stage clinical trials
for the treatment of GHD in children and adults. Somavaratan is
intended to reduce the burden of daily injection therapy by
requiring significantly fewer injections, potentially improving
adherence and, therefore, treatment outcomes. For more information
on Versartis, visit www.versartis.com.
1 Genotropin is a registered trademark of Pfizer Inc.
Contacts:
Corporate Communications: Christine Labaree Corporate
Affairs
(650) 600-1697 clabaree@versartis.com
Investors:
David Burke
Director, Investor Relations (650)
516-2703 dburke@versartis.com
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