http://www.versartis.com () —
Versartis, Inc., an emerging biotechnology company developing novel
therapeutics for patients with endocrine disorders, today announced
that it has initiated a Phase 1 clinical trial for its lead product
candidate VRS-317 for the treatment of growth hormone deficiency.
VRS-317 is a once monthly form of recombinant human growth hormone
(rhGH) which is expected to provide greater convenience and compliance
than currently available daily therapies.
The primary objective of this Phase 1 trial is to evaluate the safety
and tolerability of a single subcutaneous dose of VRS-317. The
double-blind, placebo-controlled, single-ascending dose Phase 1 trial
will enroll up to 50 adult patients with growth hormone deficiency
(GHD) in the United States and Europe. The adult GHD patients will be
withdrawn from daily rhGH therapy and, after a withdrawal period, will
receive either a single subcutaneous dose of VRS-317 or placebo. The
extent and duration of pharmacodynamic responses to VRS-317 (or
placebo) will be evaluated in each patient and compared to prior daily
rhGH therapy. Preclinical data previously presented have demonstrated
that VRS-317 provides comparable biological activity and safety to
daily rhGH with a lower total monthly dose of rhGH.
"VRS-317 has the potential to be the first once monthly treatment for
growth hormone deficiency with a profile appropriate for the treatment
of both adult and pediatric GHD patients," said Jeffrey L. Cleland,
Founder and Chief Executive Officer of Versartis.
Endocrinologist Mark Kipnes, M.D., Executive Vice President, Medical
Affairs, Cetero Research, and the principal investigator of the
VRS-317 Phase 1 study noted, "A single monthly dose of VRS-317 offers
a great deal of promise for improving treatment of growth hormone
deficient patients. I look forward to leading this important study to
establish VRS-317 as a significant advancement for the treatment of
GHD patients."
Upon completion of this initial study, the company plans to conduct
additional clinical trials in both adult and pediatric GHD patients.
Versartis has exclusive worldwide rights to develop and commercialize
VRS-317, which utilizes the proprietary Amunix XTEN half-life
extension technology.
About VersartisVersartis, Inc. is a biotechnology company developing
therapeutics for the treatment of endocrine disorders. The company's
lead product candidate is VRS-317, a once monthly form of human growth
hormone. Versartis is pursuing the development of new therapeutic
proteins utilizing the proprietary Amunix half-life extension XTEN
technology. XTEN is a novel hydrophilic sequence of natural amino
acids and is expressed as a fusion protein with a therapeutically
active peptide or protein. New compounds developed by Versartis using
the XTEN technology are expected to provide improved therapeutic
outcomes such as enhanced efficacy/compliance, fewer side effects,
prolonged half-life (up to monthly dosing), as well as low-cost
production and enhanced stability. Further information on Versartis
can be found at www.versartis.com (http://www.versartis.com/) .
