SOURCE: Versartis

Versartis

June 20, 2010 16:30 ET

Versartis Presents Results of Three Studies at ENDO 2010

Growth Deficiency Advisory Board Greatly Expanded

MOUNTAIN VIEW, CA--(Marketwire - June 20, 2010) -  Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with metabolic diseases and endocrine disorders, announced positive results of the company's VRS-317, a once monthly form of human growth hormone, today in San Diego at ENDO 2010: The 92nd Annual Meeting of the Endocrine Society. During the meeting, the company also introduced 9 new members of its VRS-317 Clinical Advisory Board (CAB), which now comprises 14 renowned growth deficiency endocrinologists.

"The members of our original Clinical Advisory Board were instrumental in helping us to design key preclinical experiments, which have been completed, and also to design the Phase I study in growth hormone deficient adults for VRS-317, which will be initiated in the fourth quarter of 2010," said Jeffrey L. Cleland, Ph.D., Versartis Chief Executive Officer. "With our mutual commitment to improving the lives of these patients, Versartis and our original advisors were able to attract additional distinguished endocrinologists to our CAB."

VRS-317 Growth Deficiency Clinical Advisory Board
The newest members of the VRS-317 CAB:
Barry Bercu, M.D., Professor of Pediatrics, University of South Florida College of Medicine
Pinchas Cohen, M.D., Chief of Endocrinology, Mattel Children's Hospital, UCLA
Paul Czernichow, M.D., Professor des Universites, Endocrinologie, Hospital Necker Enfants Malades
Paul Desrosiers, M.D., Professor of Pediatrics, Arnold Palmer Hospital for Children
Vera Popovic-Brkic, M.D., Ph.D., Institute of Endocrinology, University Clinical Center, Belgrade
Sally Radovick, M.D., Division Director of Endocrinology, Johns Hopkins Medical Institutes
Ed Reiter, M.D., Chair, Department of Pediatrics, Baystate Medical Center, Tufts University
Steve Rosenthal, M.D., Associate Program Director, Pediatric Endocrinology, UCSF
Christian Strasburger, M.D., Chief Endocrinology, Charité-Universitätsmedizin, Berlin

Charter members of the VRS-317 CAB:
Beverly Biller, M.D., Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
Gudmundur Johannsson, M.D., Professor of Medicine, Dept of Endocrinology, Gothenburg University
Mark Kipnes, M.D., Executive Vice President, Medical Affairs, Cetero Research/DGD Research
Ron Rosenfeld, M.D., Formerly of Lucille Packard Foundation and Oregon Health Sciences, Pediatric Endocrinology
Paul Saenger, M.D., Professor of Pediatrics Emeritus, Albert Einstein College of Medicine

Endocrine Society Meeting 2010
Sunday, June 20, 2010

"A Novel Human Growth Hormone XTEN Construct (VRS‐317) for Monthly Administration: Long Half-life and Sustained In Vivo Potency" 
Poster Presentation, P2‐353
1:30 ‐ 3:30 pm

VRS-317 consists of natural human growth hormone and a long tail of natural amino acids, referred to as XTEN, at the N and C termini of hGH. VRS-317 has been shown to sustain growth and pharmacodynamic (PD) responses in animals. Single doses of VRS-317 stimulated a sustained PD response in monkeys for one month and the terminal elimination half-life of VRS-317 in monkeys was 110 hr. Lipoatrophy studies indicated that VRS-317 is rapidly and near completely absorbed after subcutaneous injection and does not cause lipoatrophy in pigs or monkeys. A repeat dose (3 month) study in juvenile monkeys indicated that VRS-317 was safe and well tolerated up to 1.4 mg/kg every 28 days. Overall, these results suggest that a monthly dose of VRS-317 of approximately 0.5 mg/kg may provide a comparable growth response and safety profile to daily hGH products in growth hormone deficient children.

Commenting on the results presented today at ENDO, Paul Saenger, M.D., Professor of Pediatrics Emeritus, Albert Einstein College of Medicine, stated, "The preclinical efficacy and pharmacokinetic data suggested that the expected monthly dose of VRS-317 could be no more than 1.5 mg/kg in pediatric patients, providing a promising, long‐acting rhGH treatment for children with growth hormone deficiency."

Monday, June 21, 2010

"The Combination of a Long Acting GLP‐1 Analog (E‐XTEN; VRS‐859) and Long Acting Glucagon (Gcg‐XTEN; AMX‐808) for Superior Weight Loss and Glycemic Control in Treatment of Type 2 Diabetes and Obesity"
Oral Presentation OR24‐4
11:15 am, Room 29ABC

"A Monthly Dosed GLP-1 Analog for Treatment of Type 2 Diabetes Mellitus"
Poster Presentation P3-517
1:30 - 3:30 pm

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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