- 36-month data in pediatric GHD, showing consistent safety and efficacy profile through 3 years of treatment
- Baseline characteristics of Phase 3 VELOCITY study population comparable to Phase 2
- Additional results from the VITAL trial in adult GHD
MENLO PARK, Calif., Jan. 30, 2017 (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), announced that somavaratan data will be featured in two oral presentations and three poster presentations during the Endocrine Society's 99th Annual Meeting & Expo (ENDO 2017), to be held April 1-4, in Orlando, Florida. The abstracts have now been published online and are available on the ENDO 2017 website. Information in the abstracts is as of the submission deadline in November 2016 and may be updated at the time of presentation in April.
“As we look ahead to September and the release of our Phase 3 data in pediatric GHD as well as the planned start of a Phase 3 trial in adult GHD later this year, we are gratified to have the opportunity to present our latest somavaratan data at the premier scientific venue for endocrinology,” said Colin Hislop, MD, Chief Medical Officer. “We are highly encouraged by the preliminary data from pediatric patients who have continued on somavaratan for three years. We have seen a safety profile similar to daily rhGH products and overall somavaratan growth that compares well with results from the US based registries of daily therapy. In adults, the results of our VITAL trial have informed our dosing and titration strategy and we believe we are well positioned to move into Phase 3.”
Pediatric GHD
ORAL PRESENTATION (Oral Session: OR31-1) Monday, April 3, 2017 - 11:15 AM - 12:45 PM 31135 - Safety and Efficacy of Somavaratan (VRS-317), a Long-Acting Recombinant Human Growth Hormone (rhGH), in Children with Growth Hormone Deficiency (GHD): 3-Year Update of the VERTICAL & VISTA Trials (NCT01718041, NCT02068521)
POSTER PRESENTATION (Poster Board: SAT 016) Saturday, April 1, 2017 - 1:00 – 3:00 PM 31202 - Achievement of a Suitable Basis of Comparison in Phase 2 and Phase 3 Pediatric Somavaratan Clinical Trials (VERTICAL, VISTA, and VELOCITY Studies) and for the Comparison of Somavaratan to Daily Recombinant Human Growth Hormone (rhGH)
POSTER PRESENTATION (Poster Board: SAT 015) Saturday, April 1, 2017 - 1:00 – 3:00 PM 29268 - IGF Family Biomarkers in the Diagnosis of Pediatric Growth Hormone Deficiency (PGHD) in Somavaratan Clinical Trials
Adult GHD
ORAL PRESENTATION (Oral Session: OR22-2) Saturday, April 1, 2017 - 11:30 AM - 1:00 PM 31263 - Somavaratan, a Long-Acting Recombinant Human Growth Hormone (rhGH), for the Treatment of Adults with Growth Hormone Deficiency (AGHD): Results of VITAL, an Open-Label, Dose-Finding, International, Phase 2 Study (NCT02526420)
POSTER PRESENTATION (Poster Board: SUN 440) Sunday, April 2, 2017 - 1:00 – 3:00 PM 31432 - Correlation Between Baseline IGF-I, Dose, and Response to Once-Monthly Somavaratan, a Long-Acting Recombinant Human Growth Hormone (rhGH), in the Open-Label, Dose-Finding, International, Phase 2 VITAL Study in Adults with Growth Hormone Deficiency (AGHD) (NCT02526420)
About Somavaratan Somavaratan is Versartis' investigational, novel, long-acting form of recombinant human growth hormone (rhGH). This fusion protein consists of rhGH and specific sequences of naturally-occurring hydrophilic amino acids based on a proprietary XTEN ®1 technology. Somavaratan has been designed with the goal of improving therapeutic outcomes for children and adults with growth hormone deficiency (GHD), including enhanced adherence and convenience with a twice-monthly dosing schedule, fine gauge needle autoinjector device and room temperature storage.
Somavaratan is currently being evaluated for the treatment of pediatric GHD in the pivotal Phase 3 VELOCITY trial in the U.S., Canada and Europe, for which data are anticipated in September 2017, and the J14VR5 Phase 2/3 trial in Japan. Confirmatory safety and efficacy data from 36 months of dosing in the Phase 2 trial and VISTA long-term safety study are scheduled to be presented during the Endocrine Society 2017 annual meeting. In adult GHD, results have been reported from the Phase 2 VITAL trial in the U.S., Europe and Australia and a Phase 3 trial is expected to begin by the end of 2017.
1 XTEN is a registered trademark of Amunix Operating Inc.
About Versartis, Inc. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults. Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving adherence and, therefore, treatment outcomes. 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 molecular 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 and in our Quarterly Report on Form 10-Q for the three months ended September 30, 2016, which are 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.
Contacts: Corporate Communications: Christine Labaree Corporate Affairs (650) 600-1697 clabaree@versartis.com Investors: David Burke Director, Investor Relations (650) 516-2703 dburke@versartis.com
