- Confirms Phase 3 Data Expected Late September
MENLO PARK, Calif., July 27, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced financial results for the second quarter ended June 30, 2017, and provided an update on its clinical development programs.
“This is a time of tremendous excitement for Versartis as we approach our most significant milestone to date: the topline results from our Phase 3 VELOCITY trial of somavaratan in pediatric GHD patients,” said Jay Shepard, Chief Executive Officer of Versartis. “With our last patient visits expected in late August, we anticipate topline results around the end of September. Our confidence in somavaratan is supported by three years of data suggesting a solid safety profile and efficacy comparable to U.S. registries on the key parameters, as well as baseline characteristics in our VELOCITY trial arms that are well balanced and in line with our Phase 2 patient population. We look forward to reporting the trial outcome in the very near future, as we continue our work to prepare a strong regulatory package for submission to the U.S. Food and Drug Administration.”
“Adding to this excitement is the enthusiasm we are experiencing at clinical trial sites participating in VISTA,” continued Mr. Shepard. “Through our ongoing dialogue with physicians, patients and advocacy groups, we recognize the burden of daily rhGH injections and the desire for less frequent dosing. By expanding enrollment in our VISTA study, we are increasing the overall number of pediatric patients treated with twice-monthly somavaratan while also collecting ‘real world’ data that will be valuable to physicians and patients if approved.”
Corporate Highlights & Milestones
- Expanded enrollment of the ongoing VISTA (Versartis Long-Term Safety Study of Somavaratan) study of somavaratan in pediatric GHD to accommodate additional patients who will initiate twice-monthly somavaratan therapy
- Exceeded the initial target of enrolling 300 patients in the study; expect to have over 400 children exposed to the 3.5 mg/kg twice-monthly dose of somavaratan by Q3 2017, 300 of which are expected to have 6 months or more of continuous exposure at the time of BLA filing
- Additions will include patients newly diagnosed with GHD as well as those switching from daily rhGH therapy
- Three abstracts featuring somavaratan data through three years of treatment in the VERTICAL/VISTA pediatric GHD studies accepted for presentation at the 10th Annual International Joint Meeting of Pediatric Endocrinology (IMPE), to be held September 14-17 in Washington D.C.; VELOCITY data will not be available for presentation at IMPE
- Appointed Eric Dobmeier, current Chief Operating Officer of Seattle Genetics, to the Board of Directors, adding further depth to the board with his executive and board member experience at biotech companies
Upcoming Anticipated Milestones and Other Events
- Report topline data from the pediatric Phase 3 VELOCITY trial around the end of September
- Complete enrollment of Phase 3 Japan trial in H2 2017
- Observe a corporate quiet period beginning August 11 and leading up to the VELOCITY trial results; external communications expected to be limited primarily to announcements relating to planned IMPE presentations
Second Quarter 2017 Financial Results
