NEW YORK, NY--(Marketwire - October 04, 2010) - Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with metabolic diseases and endocrine disorders, will present preclinical data that provides the basis for its upcoming Phase 1a clinical trial of the investigational product VRS-317 for growth hormone deficiency. VRS-317 is a once monthly form of recombinant human growth hormone (rhGH). The oral presentation, "A Novel Human Growth Hormone XTEN Construct (VRS-317) for Once-a-Month Subcutaneous Administration," will be presented by Versartis Chief Executive Officer Jeffrey L. Cleland, Ph.D., at the 5th International Congress of the GRS and IGF Society in New York on Monday, October 4 at 11:00 AM.
"We are very encouraged by our latest results and the potential of VRS-317 to provide patients with a safe, effective and long acting treatment option that would clearly be a new milestone in the treatment of growth hormone deficiency," noted Dr. Cleland. "We now have preclinical data indicating that VRS-317 may be dosed at a lower total rhGH dose level once per month using a fine gauge needle, compared to the currently available daily rhGH products, while achieving the same biologic effects. In addition, robust safety data indicate a large safety factor ( > 100 fold) to support the adult growth hormone deficient (GHD) patient study planned to enroll patients in 2011."
Preclinical data have demonstrated that VRS-317 provides comparable efficacy and safety to daily rhGH with a lower total monthly dose of rhGH. Studies in hypophysectomized rats and juvenile and adult monkeys indicated that sustaining a plasma level of 1 nM or greater provided equal efficacy and pharmacodynamic responses to daily rhGH. After subcutaneous treatment administration to monkeys, VRS-317 was rapidly and near completely absorbed with a terminal elimination half-life of approximately 110 hours, supporting monthly dosing. VRS-317 did not cause lipoatrophy in pig and monkey studies. The no observable adverse effect (NOAEL) level in the GLP monkey toxicology study was the highest dose tested (25 mg/kg). To date, only 2 out of more than 40 monkeys have generated a weak immune response to VRS-317 and the response was specific to rhGH, not XTEN. Taken together, these results indicate that monthly dosing of VRS-317 in adult and pediatric GHD patients may provide comparable efficacy to daily rhGH at a lower total rhGH dose without immunogenicity or lipoatrophy concerns.
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, fewer side effects, prolonged half-life (up to monthly dosing), as well as low cost production and enhanced stability.
Versartis, Inc. is a biotechnology company developing therapeutics for the treatment of metabolic diseases and endocrine disorders. The company's lead product candidates are VRS-859, a once monthly form of the GLP-1 analog, exenatide and VRS-317, a once monthly form of human growth hormone. Versartis is pursuing the development of new therapeutic proteins utilizing the Amunix Inc. novel half-life extension XTEN technology.
Versartis, a joint venture company between Amunix, Inc. and Index Ventures, owns and develops the novel drug candidates in metabolic diseases and endocrinology that it has licensed from Amunix. Versartis has established preclinical proof-of-concept for three product candidates in its pipeline: exenatide and IL-1ra for diabetes, and hGH for growth hormone deficiency. Further information on Versartis can be found at www.versartis.com.