MENLO PARK, Calif., Dec. 29, 2014 (GLOBE NEWSWIRE) -- Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company developing a novel, long-acting form of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD), today announced it will hold a conference call and webcast on Monday, January 5, 2015 at 8:30 a.m. ET (5:30 a.m. PT).
During the call, Versartis management will provide a safety and efficacy update on pediatric GHD patients currently enrolled in its ongoing long-term Extension Study with VRS-317. Pediatric patients completing the Phase 2a VERTICAL trial were offered the opportunity to continue therapy in the Extension Study and approximately 95% of the Phase 2a patients elected to participate. The Extension Study clinical update will also be announced in a press release prior to the call.
Conference Call and Webcast
Versartis will hold a conference call on Monday, January 5, 2015 at 8:30 a.m. ET (5:30 a.m. PT). The dial-in numbers are (877) 407-0789 for domestic callers and (201) 689-8562 for international callers. A live webcast of the conference call will be available online from the investor relations page of the Company's corporate website at www.versartis.com.
After the live webcast, a replay will remain available on the Versartis website, www.versartis.com, for 90 days. In addition, a telephonic replay of the call will be available until January 19, 2015. The replay dial-in numbers are (877) 870-5176 for domestic callers and (858) 384-5517 for international callers. Please use the replay conference ID number 13598346.
The VRS-317 VERTICAL Study
The Versartis Trial In Children to Assess Long-Acting Growth Hormone (VERTICAL) study was conducted in approximately 25 US pediatric endocrinology centers and enrolled 64 treatment-naive, pre-pubertal children with GHD documented by auxologic criteria and two growth hormone (GH) stimulation tests.
The VERTICAL trial consisted of two stages: a single ascending dose stage (Phase 1b) to determine the safety, PK and PD of VRS-317 doses and to enable selection of dose regimens, which were then used in the repeat-dose second stage (Phase 2a).
The primary endpoint of the Phase 2a study was mean 6-month height velocity. Based on observed PK/PD results, 64 subjects were enrolled in the Phase 2a stage and randomized into three cohorts to evaluate three different dosing regimens of VRS-317: 5.0 mg/kg monthly, 2.5 mg/kg semi-monthly or 1.15 mg/kg weekly. At the start of repeat dosing, the subjects (37M/27F) had a mean (SD) age of 7.8 (2.4) years, HT-SDS of -2.5 (0.5) and IGF-I SDS of -1.7 (0.8).
Results from the completed Phase 2a stage of the VERTICAL study were first reported on June 23, 2014 at the 16th International Congress of Endocrinology and The Endocrine Society's 96th Annual Meeting and Expo (ICE/ENDO) in Chicago, IL and announced in the following press release: http://ir.versartis.com/releasedetail.cfm?ReleaseID=856043
As disclosed on its third quarter 2014 financial results conference call, Versartis expects to begin enrollment of its Phase 3 VELOCITY Study of VRS-317 in early 2015.
The VRS-317 Phase 3 VELOCITY Study
The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY Study) is a randomized, open-label, Phase 3 registration study in the United States, Western Europe and Canada. This study will enroll up to 136 treatment-naïve, pre-pubertal children with GHD and will include a 3:1 randomization of 3.5 mg/kg VRS-317 semi-monthly to daily rhGH at the highest labeled dose of Genotropin® (somatropin [rDNA origin] for injection) and Norditropin® (somatropin [rDNA origin] for injection) 34 µg/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12 month height velocity. GHD patients enrolling in this study will also be offered the opportunity to enroll in the ongoing Extension Study.
About Versartis
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD). VRS-317 is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and adherence and, therefore, treatment outcomes. The Company completed a Phase 2a clinical trial evaluating weekly, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD in June, 2014 and is initiating a Phase 3 study in the same patient population in early 2015. 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. We may, in some cases, use terms such as "expects" "intend," "potential," "will" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: plans regarding our anticipated Phase 3 VELOCITY study and potential benefits of and market opportunity for VRS-317. These statements 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 VRS-317; VRS-317 being a new chemical entity; serious adverse side effects, if they are associated with VRS-317; VRS-317 may not have favorable results in later clinical trials or receive regulatory approval; other long-acting rhGH products and product candidates have failed to generate commercial success or obtain regulatory approval; delays in enrollment of patients in our clinical trials could increase our costs and cause delay; VRS-317 may cause serious adverse side effects or have properties that delay or prevent regulatory approval or limit its commercial profile; manufacturing; if approved, risks associated with market acceptance, including pricing and reimbursement; our ability to enforce our intellectual property rights; the importance of 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" section contained in our Quarterly Report on Form 10-Q for the 3 months ended September 30, 2014, 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.