SAN DIEGO, CA--(Marketwire - June 24, 2011) - Diartis Pharmaceuticals, Inc. announced today that it will present data from its ongoing Phase 1 clinical trial of VRS-859 (exenatide-XTEN) at the American Diabetes Association's 71st Scientific Sessions, which began today in San Diego. VRS-859, a once monthly form of the GLP-1 analog, exenatide, is being developed to address the significant unmet needs in type 2 diabetes mellitus (T2DM) patients. The Diartis poster -- "A Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics after Subcutaneous Administration of VRS-859 in Patients with Type 2 Diabetes Mellitus" -- will be presented on Saturday, June 25 from 11:30 am to 1:30 pm (Poster Presentation 1016-P).
Jeffrey L. Cleland, Ph.D., Diartis Chief Executive Officer, will be present at the poster session to describe the most recent safety, tolerability, and pharmacokinetic (PK) results from the company's Phase 1 clinical trial in T2DM patients. The Phase 1 multi-center, blinded, placebo-controlled, single-ascending dose study is currently ongoing to evaluate the safety and the ability of VRS-859 to maintain glycemic control for one month in T2DM patients after a single dose.
"We continue to be pleased with the safety and PK profile of VRS-859," commented Dr. Cleland. "The initial Phase 1 results in patients demonstrate that the three doses administered to date (up to 50 mg VRS-859) were well tolerated and no unexpected adverse events were noted. Furthermore, the PK of VRS-859 in these patients was comparable to the profile expected based on preclinical data, validating the half-life extension capability of the XTEN technology and supporting a once monthly dosing regimen. We are proceeding with dose escalation to the predicted monthly dose of 100 mg VRS-859."
The Phase 1 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. The complete results of this Phase 1 study are anticipated later this year. The Phase 1 study will be followed by a repeat dose study comparing VRS-859 to Byetta® (exenatide injection) in T2DM patients.
About Diartis Pharmaceuticals
Diartis Pharmaceuticals, Inc. is a privately held biopharmaceutical company with headquarters in Mountain View, CA. Diartis develops novel biologics with enhanced properties to provide improved therapeutic outcomes to patients with metabolic disease. Diartis acquired the VRS-859 (exenatide-XTEN) program from Versartis, Inc. and continues its development for T2DM. 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 Diartis using the XTEN technology are expected to provide improved therapeutic outcomes such as enhanced efficacy/compliance, fewer side effects, prolonged half-life (up to monthly dosing), as well as low-cost production and enhanced stability. Further information on Diartis can be found at www.diartispharma.com.