Diartis Pharmaceuticals, Inc. is presenting positive data from its completed Phase 1 multicenter clinical trial of VRS-859 (exenatide-XTEN) at the European Association for the Study of Diabetes (EASD) 48th Annual Meeting which began on October 1 in Berlin-Charlottenburg. VRS-859, a long-acting glucagon-like peptide-1 (GLP-1) analog, is being developed as a once monthly treatment for patients with type 2 diabetes mellitus (T2DM). The Diartis poster -- "Safety, pharmacokinetics, and pharmacodynamics of a single subcutaneous dose of VRS-859 in patients with type 2 diabetes" -- will be discussed by Jeffrey L. Cleland, Ph.D., Diartis Chief Executive Officer on Wednesday, October 3.
The Phase 1 multicenter, blinded, placebo-controlled, single-ascending dose study was designed to evaluate the safety and tolerability of VRS-859 as well as the ability to maintain glycemic control for one month in T2DM patients after a single dose.
Dr. Cleland stated, "We are very pleased with the robust results seen in this initial Phase 1 study as the current data suggests repeated dosing of 200 mg VRS-859 per month will be well tolerated. Most notable were the statistically significant reductions in HbA1c levels at 30 days after only a single 200 mg dose of VRS-859, which is predicted to have a reduction in HbA1c of 1.6 to 2.2% at 6 months."
The Phase 1 results in T2DM patients demonstrate that all doses administered (up to 200 mg) were well tolerated and no unexpected adverse events were noted. Furthermore, the PK of VRS-859 in these patients was dose linear and comparable to the profile predicted from preclinical studies, validating the half-life extension capability of the XTEN technology and supporting a once monthly dosing regimen for VRS-859. These results support the company's plan to conduct a 6-month repeat dose study to determine a safe and efficacious subcutaneous dose of VRS-859 in patients with T2DM.
About VRS-859The compound has been designed to provide improved therapeutic outcomes for T2DM patients including robust and sustained improvements in HbA1c, improved tolerability, prolonged half-life (up to monthly dosing), as well as enhanced administration of a liquid formulation via a fine-gauge needle. It is hoped that upon successful development, VRS-859 may allow T2DM patients to safely manage their glucose with a therapy that is superior to current treatments for diabetes.
About Diartis PharmaceuticalsDiartis Pharmaceuticals, Inc. is a privately held biopharmaceutical company with headquarters in Redwood City, CA. Diartis develops novel biologics with enhanced properties to provide improved therapeutic outcomes to patients with metabolic diseases. The company's initial focus is the development of a long-acting GLP-1 receptor agonist that conveniently delivers maximum glucose control, aids compliance and adherence via less frequent administrations, and has improved GI tolerability.
Further information on Diartis, VRS-859, and the XTEN technology can be found at www.diartispharma.com.