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Versartis, Inc.
, an endocrine-focused biopharmaceutical company that is
developing a novel, long-acting form of recombinant human growth hormone
(rhGH), today announced it was selected to present data from its ongoing
Extension Study of pre-pubertal children with moderate growth hormone
deficiency (GHD) in a poster presentation at The Endocrine Society's 97^th
Annual Meeting & Expo (ENDO 2015) in San Diego, CA. While previously disclosed
(see press release), this is the first time the results are being presented in
a scientific meeting. George Bright, MD, Versartis Vice President of Clinical
Development, will discuss the results at the clinical poster session
"Late-breaking Pediatric Endocrinology II" from 1:00 – 3:00 p.m. PT today.
"We are excited to have data from our ongoing pediatric Extension Study
selected as a late-breaking poster presentation at the ENDO 2015 Annual
Meeting. These data demonstrated a dose response in the subset of patients
that were switched to a higher dose of VRS-317 on a semi-monthly basis, while
maintaining safety and tolerability in line with results from our Phase 2a
study," said Jeffrey L. Cleland, PhD, Chief Executive Officer. "Importantly,
VRS-317 showed less waning of growth response over the 12 month period when
compared to current daily rhGH therapy. With these results in hand, we have
further confidence in the design of our global Phase 3 VELOCITY study, which
was initiated in January 2015."
Highlights from the Poster Presentation
* VRS-317 is safe and well tolerated after 12 months of treatment
* Lower rate of related adverse events in second 6 months
* All regimens provide similar IGF-I responses comparable to those of daily
rhGH and with minimal excursions of IGF-I SDS exceeding 2
* Dose response confirmed by IGF-I SDS moving up nearly 1.0 standard
deviation (SD); this was achieved by increasing the dose from 2.5 to
3.5mg/kg semi-monthly
* Adjusting VRS-317 dose from 2.5 mg/kg semi-monthly to 3.5 mg/kg
semi-monthly resulted in:
* Expected increase in IGF-I response (mentioned above) without
overexposure
* Patients who switched from 1.15 mg/kg weekly to 3.5 mg/kg
semi-monthly (n=5) experienced a height velocity increase from 7.5 to
9.3 cm/yr
* Less waning of the growth response was observed over the first 12 months
of VRS-317 treatment than typically observed with daily rhGH therapy
The Extension Study's primary objective is to study the safety and efficacy of
long-term treatment with VRS-317 in pre-pubertal GHD children and to evaluate
the effect of a dose increase on IGF-I and height velocity within a subset of
the GHD children. In the ongoing Extension Study, subjects in the Phase 2a
study on a VRS-317 dose of either 2.5 mg/kg semi-monthly or 5.0 mg/kg monthly
were continued on the same dose for an additional 6 months. Subjects in the
Phase 2a study on a VRS-317 dose of 1.15 mg/kg weekly (5 mg/kg/month) were
switched to 3.5 mg/kg semi-monthly (7 mg/kg/month) upon their first visit
after the completion of the Phase 2a study. Subjects enrolled in the Extension
Study as they completed the six months of treatment in the Phase 2a study.
Poster and Program Details:
Title: "Dose Response and 12-Month Safety and Efficacy of VRS-317 in
Pre-Pubertal Children with Moderate Growth Hormone Deficiency (GHD)"
Program: Abstracts – Poster Viewing with Presenters
Session: LBF 024-030 Late-breaking Pediatric Endocrinology II
Poster: Poster Board LBF-026
Location: Hall D-F (San Diego Convention Center)
Date: Friday, March 6, 2015: 1:00 – 3:00 p.m. PT
The poster can be viewed by CLICKING HERE and is also available online within
the "EVENTS AND PRESENTATIONS" section of the Company's investor relations
website at www.versartis.com.
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