Versartis Initiates Phase 1 Clinical Trial of VRS-317 Monthly Human Growth Hormone Therapy
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Versartis, Inc., has 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The adult GHD patients will be withdrawn from daily rhGH therapy and, after a withdrawal period, will receive either a single subcutaneous dose of VRS-317 or placebo.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.