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Versartis, Inc. Phase 1 Clinical Results of Once Monthly Human Growth Hormone Presented to European Society for Paediatric Endocrinology


9/24/2012 8:53:58 AM

LEIPZIG, GERMANY--(Marketwire - September 22, 2012) - Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with endocrine disorders, presented positive results from its completed clinical trial of VRS-317, the company's proprietary once monthly form of recombinant human growth hormone (rhGH). The oral discussion of "Safety and Tolerability of a New Long Acting Human Growth Hormone (VRS-317) in Adult GH Deficiency" was presented by Versartis Vice President of Medical Affairs George M. Bright, MD, during ESPE 2012: The 51st Annual Meeting of the European Society for Paediatric Endocrinology.

"The clinical data presented today demonstrate that single doses of VRS-317 sustained IGF-1 responses in the normal range in a dose dependent and tunable manner," Dr. Bright stated. "Based on its potential to provide persistent biological responses for up to one month, VRS-317 is currently the only long acting rhGH compound with a future for once monthly dosing."

Versartis Chief Executive Officer Jeffrey L. Cleland, PhD, said, "We are very pleased with the recent clinical results observed in adults with GHD, and believe that the opportunity to present these findings to the pediatric endocrinology community is further evidence of the important potential that exists for VRS-317 to address the needs of patients with GHD."

The primary objective of the Phase 1 study was to evaluate the safety and tolerability of a single subcutaneous (SC) dose of VRS-317. The 60-day, double-blind, randomized, placebo-controlled, single-ascending dose Phase 1 trial enrolled 50 GHD adult patients in the United States and Europe.

Results presented by Dr. Bright demonstrated that single doses of VRS-317 were safe and well tolerated. Adverse events (AEs) that were considered drug related were primarily mild and transient. There were no reported SAEs, no unexpected AEs and no injection site lipoatrophy observed during treatment. No significant post-dosing changes were observed for fasting glucose, post-prandial glucose or fasting insulin. Substantial reductions in cholesterol, triglycerides and LDL were observed in GHD patients receiving 0.80 mg/kg VRS-317. VRS-317 was rapidly absorbed, achieving a Tmax 2-3 days after a single SC dose. The half-life of VRS-317 increased significantly (p=0.016) as a linear function of increased dose with a maximum mean terminal half-life of 131 hours at the 0.80 mg/kg dose of VRS-317. The PD profile of VRS-317 indicated that IGF-1 was normalized in a dose-dependent manner with the duration of IGF-1 normalization increasing with dose, thus enabling up to once monthly dosing for future clinical trials.

About Versartis
Versartis, 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.


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