Versartis Announces Two Abstracts from Ongoing Pediatric Extension Study of Somavaratan Selected for Late-Breaker Presentations at the Endocrine Society’s 98th Annual Meeting
MENLO PARK, Calif., March 14, 2016 (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 detailed two-year, safety, efficacy and adherence data from its ongoing Extension Study of somavaratan in children with GHD will be featured in two late-breaker presentations at the Endocrine Society’s 98th Annual Meeting & Expo (ENDO 2016), to be held April 1-4, 2016, in Boston, MA. The Extension Study is a long-term safety study that was initiated in March 2014 as patients completed the Phase 1b/2a clinical trial evaluating somavaratan therapy in treatment-naive, pre-pubertal GHD children.
Bert Bakker, MD, PhD, Senior Vice President, Medical Affairs, commented, “We are very pleased to have in-depth confirmatory data from our ongoing pediatric Extension Study selected for two late-breaker presentations at this year’s Endocrine Society Annual Meeting. We appreciate that the Endocrine Society recognizes that the important results coming from Versartis’ ongoing clinical trial program in Pediatric GHD patients would be of interest to meeting attendees. We look forward to sharing details on the safety, efficacy and patient adherence of somavaratan at this important event for the global endocrinology community.”
The abstracts are now available on the ENDO website and can be accessed using the links below.
Dosing adherence data from the Extension Study will be presented during a poster session on Friday, April 1, 2016 from 1:15 p.m. — 3:15 p.m. Eastern Time (ET):
Abstract LBFri-01: “Adherence with Weekly, Twice-Monthly and Monthly Dosing Schedules of Somavaratan (VRS-317) Long Acting Growth Hormone Treatment in Children with Growth Hormone Deficiency (GHD) after 18 Months of at-Home Dosing,” Humphriss, et al.
Year 2 safety and efficacy data from both the Phase 2a and Extension Studies will be highlighted in an oral session on Sunday, April 3, 2016, from 11:30 a.m. to 1:15 p.m., ET:
Abstract LB-OR02-2: “Somavaratan (VRS-317) Treatment of Children with Growth Hormone Deficiency (GHD): Results at 2 Years,” Bright, et al.
Versartis disclosed top-line results from the two-year analysis of somavaratan in pediatric patients on February 2, 2016, but preserved the detailed data for presentation during ENDO 2016.
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 in late-stage clinical trials for the treatment of growth hormone deficiency (GHD) in children and adults. Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. Versartis’ clinical trials can be found at www.versartistrials.com. For more information on Versartis, visit 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, 2015, which is on file with the Securities and Exchange Commission (SEC). 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.
