SOURCE: Versartis

Versartis

September 21, 2010 05:00 ET

Versartis Presents Data at EASD for New Diabetes Drug VRS-859 (Exenatide-XTEN)

Type 2 Diabetes Mellitus Drug for Monthly Dosing Currently in Phase I Study

STOCKHOLM, SWEDEN--(Marketwire - September 21, 2010) -  Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with metabolic diseases, will present preclinical data that supports the ongoing Phase 1a clinical trial of the company's lead product VRS-859 (exenatide-XTEN) for type 2 diabetes mellitus (T2DM). VRS-859 is a once monthly form of the GLP-1 analog exenatide. The poster (#844) will be presented by Versartis Chief Executive Officer Jeffrey L. Cleland, Ph.D., at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Stockholm on Wednesday, September 22, from 12:30 PM to 1:30 PM during the session Long Acting GLP Agonists (PS 075).

VRS-859 is a fusion protein containing the GLP-1 analog (exenatide) and a long hydrophilic tail of natural amino acids (XTEN). Mouse studies were performed to determine the relationship between the pharmacokinetics (PK) and pharmacodynamics (PD) of VRS-859. Toxicology studies were performed in mice and monkeys to ensure adequate safety for the proposed human dose. Results of these studies, to be presented at EASD, show that up to 48 hrs after IP VRS-859 dosing (120 nmol/kg), mice maintained a significant improvement in glucose tolerance, while exenatide-only demonstrated significant improvement up to 1 hr post-dose. As a result of the long projected half-life of VRS-859 in humans, active drug levels are expected to be sustained throughout each month, which would potentially increase the efficacy and decrease the acute side effects of the drug relative to other GLP-1 analogs. Therefore, a single subcutaneous 100 mg dose of VRS-859 may provide plasma levels sufficient to ensure glycemic control for one month in humans.

"Preclinical studies demonstrate that VRS-859 provides sustained glycemic control and weight loss comparable to or better than exenatide only," commented Dr. Cleland. "The ongoing Phase 1a study in T2DM patients will enable selection of the optimal dose(s) of VRS-859 to achieve monthly dosing; and we plan to initiate a multiple-ascending dose (3 months) Phase 1b study in T2DM patients later this year."

The Phase 1a multi-center, blinded, placebo-controlled, single-ascending dose study began enrollment in June and is being conducted at several selected sites throughout the world. This study is designed to assess the safety and tolerability of a single subcutaneous dose of VRS-859 in patients with T2DM. In addition, the study is designed to evaluate evidence of VRS-859 activity by measurement of fasting plasma glucose and response to oral glucose tolerance tests at selected times post-dose, as well as to evaluate post-challenge glucose excursions. This study is planned for completion by the end of 2010.

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.

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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