MENLO PARK, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317) a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that data from its ongoing pediatric Extension Study has been accepted for a late-breaker poster presentation at the upcoming 54th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE), taking place in Barcelona, Spain from October 1-3.
| Title: | Safety and Efficacy of Long-Acting Growth Hormone (VRS-317) in Children with GHD: Effects of Dose Change in the Second Treatment Year |
| Poster #: | LBP-1267 |
| Location: | Fira Barcelona Gran Via Venue, Hall 8 |
Bert Bakker, Senior Vice President, Medical Affairs, stated, ”The annual meeting of the European Society for Paediatric Endocrinology is an excellent platform for Versartis to provide an update on our ongoing Extension Study of somavaratan in pediatric patients. We appreciate that the organizing committee recognizes the importance of the Company’s trials and the positive results we have achieved as we work toward developing a safe, effective and long-acting treatment option for patients with growth hormone deficiency. We look forward to providing additional information at this event.”
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency (GHD). Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, twice-monthly and monthly dosing regimens of somavaratan in children with GHD in June 2014 and initiated a global Phase 3 registration trial, VELOCITY, in GHD children in January 2015. In addition, the Company initiated a Phase 2/3 trial in Japan for children with GHD in April 2015. Additional information on Versartis clinical trials can be found at www.versartistrials.com. Further information on Versartis can be found at www.versartis.com.
Cautionary Note on Forward Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on somavaratan; somavaratan being a new chemical entity; the risk that somavaratan may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that somavaratan may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing somavaratan; if somavaratan is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our Annual Report on Form 10-K for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission (SEC), and in our Quarterly Report on Form 10-Q for the three months ended June 30, 2015, which we expect to file with the SEC on or before August 5, 2015. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CONTACT: Corporate & Investors:
Joshua Brumm
Chief Financial Officer
(650) 963-8582
IR@versartis.com
Investors:
Nick Laudico
The Ruth Group
(646) 536-7030
nlaudico@theruthgroup.com
Media:
Debra Bannister
Corporate Communications
(530) 676-7373
media@versartis.com
