News and EventsPress ReleasesVersartis CEO Jeffrey Cleland Featured at Advancing Protein Therapeutics Conference – Monthly Dosing of Drugs for Metabolic and Endocrine Diseases is Company’s Focus – Frankfurt, Germany – April 21, 2010 – Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with metabolic diseases, will be represented at the Advancing Protein Therapeutics conference on Wednesday, April 21, by Jeffrey Cleland, Ph.D., Founder and Chief Executive Officer. Dr. Cleland’s presentation, “Matching Pharmacokinetics to Clinical Requirements” will address optimizing therapeutic, dosing and manufacturing qualities of the company’s lead products VRS-859 (exenatide-XTEN) for type 2 diabetes mellitus (T2DM) and VRS-317 (hGH-XTEN) for growth hormone deficiency (GHD). Bioribis, a global life sciences conference organization, is sponsoring this meeting in Frankfurt, Germany, April 21-22, 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. VRS-859 and VRS-317 were studied in preclinical animal models of T2DM and GHD, respectively. The pharmacokinetics (PK) of each product was assessed in multiple animal species to determine the relationship between PK and pharmacodynamics (PD). The preclinical data on VRS-859, which is an 84 kDa fusion protein, estimate the dose required to sustain a therapeutic level in type 2 diabetes patients at 100 mg once per month as a single subcutaneous injection. 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, potentially increasing the efficacy and decreasing the acute side effects of the drug relative to other GLP-1 analogs. VRS-317 preclinical studies indicate that a biological response is sustained for one month after a single dose in monkeys. The long half-life (110 hr in monkeys) and in vivo potency of VRS-317 in preclinical models suggests that a dose of 0.5 mg VRS-317/kg/month is sufficient to stimulate a growth response equivalent to daily hGH products (dosed at 1.2 – 1.5 mg hGH/kg/month) in GHD children, and lower doses may provide sustained IGF-I responses in GHD adults. “We look forward to validating these preclinical PK/PD relationships in patients. Both products provide an opportunity to significantly improve patient care with potential benefits of increased efficacy and safety along with greater convenience and compliance,” noted Dr. Cleland. VRS-859, a once monthly dosage form of the GLP-1 analog exenatide, is planned to enter a Phase I clinical trial in type 2 diabetes patients this quarter. VRS-317, a once monthly dosage form of human growth hormone (hGH), has demonstrated superiority of dosing and tolerability over other long-acting hGH analogs. Clinical trials of VRS-317 in growth hormone deficient patients are planned for the end of 2010. About Versartis 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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