Positive Preclinical Data On 2 Product Candidates At ENDO 09 Presented By Versartis

Main Category: Diabetes
Also Included In: Biology / Biochemistry;  Clinical Trials / Drug Trials
Article Date: 11 Jun 2009 - 4:00 PDT

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Versartis, Inc., an emerging company developing novel biologics with enhanced properties for patients with metabolic diseases, 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 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 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 were presented in poster sessions."

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

Source:
Debra Bannister
Versartis, Inc.