Washington, DC – June 10, 2009 – Versartis, Inc., an emerging company developing novel biologics with enhanced properties for patients with metabolic diseases, today presented data for its long-acting product candidates, VRS-317 (hGH-rPEG) for treatment of growth hormone deficiency and for VRS-826 (IL-1ra-rPEG) for treatment of type 1 and type 2 diabetes, at the Endocrine Society's Annual Meeting in Washington, DC.
Versartis, through a unique licensing agreement with Amunix, Inc., uses the Amunix proprietary recombinant PEGylation (rPEG) technology to extend the half-life of established biologics. The preclinical Versartis compounds have the potential for significantly less frequent dosing and fewer side effects than those products currently on the market or in development.
"New half-life extension data presented today for the first time confirmed our expectation that dosing can be extended from weekly to monthly for our product candidates," said Jeffrey L. Cleland, Ph.D., Founder and Chief Executive Officer of Versartis. "Our preclinical data presented today show that VRS-317 demonstrated in vivo potency equal to daily hGH, and sustained plasma levels and pharmacodynamic responses in monkeys without toxicity. Potential benefits of VRS-317 include its stability at room temperature in a liquid formulation and the ability to dose monthly with a small gauge needle, thus increasing patient safety and convenience. VRS-317 may become 'best in class' hGH therapy when our preclinical studies are confirmed in human clinical trials."
"Treatment of auto-inflammation in diabetes with IL-1ra has been demonstrated to increase beta-cell responsiveness in human clinical trials," Dr. Cleland continued. "Our new approach with VRS-826 will provide a less frequently administered treatment that should have comparable safety to IL-1ra, which binds both IL-1b and IL-1a. The results from preclinical studies of VRS-317 and VRS-826 are being presented in poster sessions this afternoon."
An Extended Half-Life Human Growth Hormone Construct for Weekly Administration
hGH-rPEG
Poster Board Number P1-720
Wednesday, June 10, 2009 1:30 - 3:30 pm
A Long Half-Life Interleukin-1-Receptor Antagonist for the Treatment of Type 2 Diabetes Mellitus
IL-1ra-rPEG
Poster Board Number P1-466
Wednesday, June 10,2009 1:30 - 3:30 pm
About Versartis
Versartis, Inc., a Redwood City, California biotechnology company, is developing therapeutics for the treatment of metabolic diseases and endocrine disorders. Versartis is pursuing the development of new therapeutic proteins utilizing the Amunix Inc. novel half-life extension recombinant PEGylation (rPEG) 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 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.
About ENDO 09
The Endocrine Society's 91st Annual Meeting, ENDO 09 is being held at the Walter E Washington Convention Center in Washington, DC, June 10-13, 2009. Approximately 7,500 scientists and clinicians from all over the world are expected to assemble for this premier meeting of hormone research, health science, and endocrinology. It is a unique opportunity for journalists to learn about the latest research in fields as diverse as diabetes, growth hormones, obesity, endocrine disrupters, sex steroids, thyroid cancer and more.