Versartis Presents Preclinical Data For Novel Type 2 Diabetes Drug

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 24 Sep 2009 - 3:00 PDT

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Versartis, Inc. today presented preclinical data demonstrating the potential for monthly dosing of its lead product, VRS-859 (exenatide-XTEN), for the treatment of type 2 diabetes. The data were presented by Jeffrey Cleland, Ph.D., Founder and Chief Executive Officer of Versartis, at the IBC Protein Engineering & Design Conference in San Diego.

In his talk, "Half-life Extension and In Vivo Biological Activity of Peptide and Protein Therapeutics," Dr. Cleland presented VRS-859 preclinical data in models of diabetes and pharmacokinetics in mice, rats, dogs and monkeys. Versartis has begun development activities for VRS-859 including manufacturing and regulatory meetings. A clinical study of VRS-859 in patients with type 2 diabetes is planned for the first half of 2010.

Versartis is also finalizing lead selection for VRS-317 (human growth hormone-XTEN), a monthly dosage form. Dr. Cleland presented preclinical proof of concept and pharmacokinetic data. Versartis plans to begin Phase I clinical trials of VRS-317 in patients with growth hormone deficiency in the second half of 2010.

In addition to the reduced dosing frequency, Versartis' XTEN products enable room temperature stability and low cost manufacturing. The XTEN properties allow for co-formulation and co-administration of proteins and peptides that are normally incompatible. Versartis is conducting research on combination products for metabolic disease to exploit these novel properties.

"Versartis is focusing on treatments for metabolic and endocrine diseases that currently require daily or weekly dosing," explained Dr. Cleland. "Our results to date demonstrate the potential for monthly dosing of our compounds. The potential for improved convenience along with other XTEN properties provide a distinct advantage for Versartis' products over other products on the market or in development."

Source
Versartis, Inc.