Versartis Initiates Phase 2/3 Trial of VRS-317 in Japan for Children With Growth Hormone Deficiency
MENLO PARK, Calif., April 13, 2015 (GLOBE NEWSWIRE) — Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced the initiation of its Phase 2/3 study of VRS-317 in Japan for children with growth hormone deficiency (GHD).
“With the initiation of our Phase 2/3 study in Japan for pediatric GHD patients, we have achieved another milestone in our efforts to commercialize VRS-317 globally,” said Jeffrey L. Cleland, PhD, Chief Executive Officer. “Japan represents a significant portion of the international pediatric GHD market. Currently, daily rhGH products in Japan are approved at lower doses than doses used in other major markets, resulting in lower growth rates for Japanese GHD children. The Phase 2/3 trial will evaluate single dose PK/PD in the Phase 2 stage followed by a twice monthly dosing regimen in the Phase 3 stage with the potential to achieve growth rates comparable to those achieved with the approved doses of daily rhGH in the U.S. If approved by Japanese regulatory authorities, we believe Versartis will have an opportunity to capture a significant market share in Japan with an effective treatment option that is also less burdensome than the current daily treatment.”
Assuming comparable safety, pharmacokinetics and pharmacodynamics between U.S. and Japanese GHD children in the Phase 2 stage, the Phase 3 stage will use the same dose under evaluation in the global Phase 3 VELOCITY trial (3.5 mg/kg VRS-317 twice monthly). The Japan Phase 3 stage will be a single arm study of twice monthly VRS-317 for 12 months and will enroll pre-pubertal naïve to treatment GHD children. The Company will also conduct an open label Extension Study in Japan to allow Phase 2/3 patients to continue treatment with VRS-317 and allow enrollment of patients switching from current daily rhGH therapy to VRS-317.
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, 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 VRS-317 in children with GHD in June 2014 and began a global Phase 3 registration trial, VELOCITY, in GHD children in January 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 “intended,” “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 or current expectations concerning, among other things, the market opportunity for VRS-317 in Japan, plans and timing of our clinical trials and benefits of 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; the potential for 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; we may encounter difficulties in manufacturing VRS-317 or in satisfying regulatory requirements related to 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” 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). 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.
Chief Financial Officer
The Ruth Group