BOSTON, MA--(Marketwire - June 05, 2011) - Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with endocrine disorders, today presented new long-term preclinical safety data for VRS-317, the company's proprietary once monthly form of recombinant human growth hormone (rhGH). The poster, "A Novel Human Growth Hormone XTEN Construct (VRS-317) for Once-a-Month Subcutaneous Administration in a Phase 1a Study of Growth Hormone Deficient Adults," was presented by Versartis Chief Executive Officer Jeffrey L. Cleland, Ph.D., at ENDO 2011: The 93rd Annual Meeting of the Endocrine Society in Boston.
VRS-317 is expected to provide an efficacious and more convenient treatment for growth hormone deficiency than currently available daily therapies. 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 and was used as the basis for the company's ongoing Phase 1 clinical trial.
Dr. Cleland commented, "The data presented today, which expands upon our initial results, demonstrated in monkeys that dosing every two weeks for three months was well-tolerated, and further supports the development of VRS-317 as the first once monthly treatment for growth hormone deficiency in both adults and children."
GLP toxicology studies in monkeys have been completed for acute (4 weeks) and long-term (13 weeks) exposure at doses up to 25 mg/kg VRS-317 administered every two weeks. The No Observed Adverse Event Level (NOAEL) was 25 mg/kg VRS-317, the highest dose studied. No lipoatrophy or anti-XTEN antibodies were detected in the toxicology studies. These results indicate that VRS-317 should have a large therapeutic window to ensure selection of a safe and efficacious dose in patients.
A Phase 1 trial to evaluate the safety and tolerability of a single subcutaneous dose of VRS-317 was initiated in Q1/2011. 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 The adult GHD patients will be withdrawn from daily rhGH therapy and, after a withdrawal period, will receive either a single subcutaneous dose of VRS-317 or placebo.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. If proven to be effective and safe in humans, once-monthly administration of VRS-317 may provide a significant improvement in the treatment of GHD patients.
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.