Versartis, Inc. Data for Type 2 Diabetes Drug VRS-859 (Exenatide-XTEN) Featured at American Diabetes Association Annual Scientific Meeting

ORLANDO, FL--(Marketwire - June 26, 2010) - Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with metabolic diseases, has been selected to have its data previewed at the invitation only President’s Poster Session Reception on Sunday, June 27, 2010, highlighting 100 posters in all areas of diabetes-related science. The Versartis poster to be featured on Sunday -- “A Monthly Dosed GLP-1 Analog for Treatment of Type 2 Diabetes Mellitus” contains data demonstrating the preclinical efficacy and safety of VRS-859 (exenatide-XTEN). This poster, and a poster entitled “XTEN-modified Glucagon and Exenatide Constructs for Improving Glycemic Control in Type 1 and Type 2 Diabetes,” will be presented on Monday, June 28 during the ADA 70th Scientific Sessions meeting being held in Orlando.

Jeffrey L. Cleland, Ph.D., Versartis Chief Executive Officer, will be present at the poster sessions to discuss the preclinical data and to describe the company’s recently initiated Phase I clinical trial in type 2 diabetes patients for monthly dosing of VRS-859.

“We appreciate that the American Diabetes Association has recognized the science behind our investigational compound VRS-859. The preclinical data suggests that VRS-859 may provide a new approach to treating diabetes patients with a potentially more efficacious, safer and convenient GLP-1 therapy than existing products,” Dr. Cleland explained. “The preclinical results have enabled the start of our first clinical trial of VRS-859 in patients, announced earlier this week.”

Versartis Posters Presented at ADA:

“A Monthly Dosed GLP-1 Analog for Treatment of Type 2 Diabetes Mellitus”
Poster Presentation 389-PP
12 - 2pm June 28, 2010

VRS-859 (exenatide-XTEN) has the same mechanism of action as exenatide in preclinical models but has a substantially longer projected human half-life (139 hr) and more sustained in vivo potency (prolonged glycemic control) than exenatide or other published GLP-1 analogs. VRS-859 is safe and well-tolerated at the highest doses tested in mice (50 mg/kg) and monkeys (35 mg/kg) in GLP toxicology studies. When combined with previous results, the preclinical safety profile of VRS-859 supports the current clinical trial designed to demonstrate safety and maintenance of glycemic control from a single monthly dose in type 2 diabetes patients.

“XTEN-Modified Glucagon and Exenatide Constructs for Improving Glycemic Control in Type 1 and Type 2 Diabetes”
Poster Presentation 617-P
12 - 2 pm June 28, 2010

VRS-859 (exenatide-XTEN) has also been investigated in combination with AMX-808 (glucagon-XTEN). The XTEN domains of these molecules enabled mixing of the two product candidates and co-administration, as well as the opportunity to adjust the relative receptor binding and pharmacokinetic profile to optimize the overall pharmacodynamic effects. Recent results suggest that the combination of VRS-859 and AMX-808 provided an increased weight loss and superior glycemic control when compared to either one alone.

Phase I Study in Type 2 Diabetes Mellitus Patients
VRS-859 is a once monthly form of the GLP-1 analog, exenatide, for patients with type 2 diabetes mellitus (T2DM). Versartis is currently enrolling patients in a Phase 1a multi-center, blinded, placebo-controlled, single-ascending dose study which is designed to demonstrate safety and the ability to maintain glycemic control for one month in T2DM patients after a single dose. The Phase 1a study will be followed by a repeat dose (3 month) Phase 1b study comparing Byetta® to VRS-859 in T2DM patients, which is planned to begin in the fourth quarter of 2010.

About Versartis
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.


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