Versartis to Hold Conference Call to Discuss Six Month VRS-317 Phase 2a VERTICAL Clinical Trial Results
Conference Call and Webcast Scheduled at 5:00 p.m. EDT on June 23, 2014
Data Presented During Poster Session at ICE/ENDO 2014
MENLO PARK, Calif., June 9, 2014 (GLOBE NEWSWIRE) -- Versartis, Inc. (VSAR), an endocrine-focused biopharmaceutical company that is 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, June 23, 2014 at 5:00 p.m. EDT (4:00 p.m. CDT).
During the call, Versartis management will discuss the results, including 6 month height velocity and safety, from the Company's completed VERTICAL trial, a Phase 1b/2a study of VRS-317 in naïve pre-pubertal children with GHD. The results will be presented at a poster presentation that afternoon from 2:00 p.m. to 4:00 p.m. EDT (1:00 p.m. to 3:00 p.m. CDT) during the International Congress of Endocrinology and Endocrine Society's Annual Meeting and Expo at the McCormick Place West in Chicago, IL. The poster is entitled "Safety and Efficacy Results of a 6 Month, Randomized, Multi-Center Trial of a Novel Long-Acting rhGH (VRS-317) in Naïve to Treatment, Pre-Pubertal Children with Growth Hormone Deficiency (GHD)." The results will also be announced in a press release at the start of the poster session.
Currently, there are seven marketed rhGH products in the US for the treatment of GHD. However, a key limitation of these products is the burden of daily injections, which can compromise compliance and lead to suboptimal treatment outcomes. As such, the Company believes that there is a significant unmet need for an improved therapeutic option for both pediatric and adult GHD patients. Versartis previously demonstrated in a Phase 1a trial in GHD adults the potential for monthly dosing in this patient population as published in Yuen et al, JCEM 2013. VRS-317 is being developed to provide up to once-monthly dosing and has the potential to improve patients' compliance to rhGH therapy and overall treatment outcomes.
Conference Call and Webcast
Versartis will hold a conference call on Monday, June 23, 2014 at 5:00 p.m. EDT (4:00 p.m. CDT). 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, the call 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 July 7, 2014. 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 13584528.
The VRS-317 VERTICAL Trial
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 naïve-to-treatment, pre-pubertal children with GHD that was documented by auxologic criteria and two GH stimulation tests.
The VERTICAL trial of VRS-317 consists 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) to obtain 6-month height velocity results.
The primary endpoint of the Phase 2a study is mean 6-month height velocity. GHD was diagnosed by short stature (HT-SDS < -2), delayed bone age, paired GH stimulation tests (GHmax d 10 ng/mL), a low IGF-I (IGF-I SDS < -1) and absence of other conditions to cause poor growth. Initially, 48 subjects (8/dose cohort) were enrolled in the Phase 1b stage and received single doses at one of six VRS-317 dose levels (0.8 to 6.0 mg/kg). Based on observed PK/PD results, 64 subjects were enrolled in the Phase 2a stage and randomized into three cohorts to evaluate 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 1b single ascending dose stage of the study were reported on September 22, 2013 at the 9th Joint Meeting of Paediatric Endocrinology in Milan and announced in the following press release: http://ir.versartis.com/releasedetail.cfm?ReleaseID=831885
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 has recently completed a Phase 2a clinical trial evaluating weekly, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD. 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 "believes," "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: the success of the Phase 2a stage of our on-going Phase 1b/2a clinical, the potential outcome of our discussions with the FDA and EMA, the potential resumption of our development of VRS-317 in adults with GHD, potential market opportunities in GHD. 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 March 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.
CONTACT: Corporate Joshua Brumm Chief Financial Officer (650) 963-8582 IR@versartis.com Investors Nick Laudico The Ruth Group (646) 536-7030 email@example.com Media Debra Bannister Corporate Communications (530) 676-7373 firstname.lastname@example.org
Source: Versartis 2014 GlobeNewswire, Inc.