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Journal of Clinical Endocrinology & Metabolism Publishes Positive Versartis, Inc. Phase I Data


4/30/2013 11:47:41 AM

REDWOOD CITY, CA--(Marketwired - April 30, 2013) - Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with endocrine disorders, said today that positive results from its first double-blind, placebo-controlled, single ascending dose study of VRS-317 in growth hormone deficient adults were published ahead of print on April 12, 2013 in the Journal of Clinical Endocrinology & Metabolism (JCEM) [doi:10.1210/jc.2013-1437] and will be published in final print in an upcoming issue of JCEM.

VRS-317 is a proprietary long-acting form of recombinant human growth hormone (rhGH). At present, the only approved growth hormone treatments require daily injections. VRS-317 is expected to provide up to once-monthly dosing. The multi-center study of VRS-317, which was published in the JCEM, was conducted in 50 adults with growth hormone deficiency (GHD). Versartis is now investigating the safety and efficacy of VRS-317 in a Phase 1b/2a clinical trial in pre-pubertal children with GHD. The Versartis Trial In Children to Assess Long-Acting Growth Hormone (VERTICAL) study is being conducted in approximately 30 clinical sites in the United States.

Versartis Chief Executive Officer Jeffrey L. Cleland, PhD, stated, "Our encouraging results published in the current issue of JCEM, along with the data from our ongoing trial in pediatric GHD patients support Phase 3 activities, which we plan to initiate next year."

George M. Bright, MD, Versartis Vice President of Medical Affairs explained, "Administration of daily recombinant human growth hormone poses a considerable challenge to patients with GHD. Reduced dosing frequency promises to improve treatment adherence and consequently, overall treatment outcomes for these patients. The reporting of our study results in a leading endocrinology journal is further evidence of the importance of addressing the unmet needs of patients with GHD."

Top Line Results
This Phase I study was the first in humans for VRS-317 and extends prior knowledge about long-acting rhGH because it represents the most prolonged duration of action of any rhGH analogue in the treatment of adults with GHD. All subjects were adults with GHD diagnosed in accordance with current consensus guidelines of The Endocrine Society, the American Association of Clinical Endocrinologists and the Growth Hormone Research Society. Outcomes measured included adverse events, safety laboratories, VRS-317 pharmacokinetics and pharmacodynamics (IGF-I, IGFBP-3). At 0.80 mg/kg, VRS-317 had a mean terminal elimination half-life of 131 hours. Single VRS-317 doses of 0.05, 0.10, 0.20, 0.40 and 0.80 mg/kg (approximately equivalent to daily rhGH doses of 0.3 to 5.0 µg/kg over 30 days) safely increased the amplitude and duration of IGF-I responses in a dose dependent manner. After a single 0.80 mg/kg dose, serum IGF-I was maintained in the normal range between -1.5 to 1.5 standard deviations (SD) for a mean of three weeks. No unexpected or serious adverse events were observed.

Study Conclusions
The elimination half-life for VRS-317 is 30-60-fold longer over those reported in package inserts for daily rhGH and stimulates more durable IGF-I responses than previously studied rhGH products. Prolonged IGF-I responses do not come at the expense of over-exposure to high IGF-I levels. The pharmacokinetic and pharmacodynamics combined with the observed safety profile indicate the potential for safe and effective dosing up to once monthly.

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 novel long-acting form of human growth hormone. VRS-317 is currently being investigated for safety and efficacy in pediatric GHD patients for up to once monthly dosing. Versartis is pursuing the development of new therapeutic proteins utilizing the proprietary Amunix half-life extension technology (XTEN). 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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