In a recent news release, Versartis, Inc. (NASDAQ: VSAR), an endocrine-focused biopharmaceutical company, announced the completion of enrollment for its phase III VELOCITY trial of somavaratan, a long-acting form of recombinant human growth hormone (rhGH) currently being evaluated for the treatment of pediatric growth hormone deficiency (GHD). The randomized, open-label registration trial will focus on pre-pubertal children with GHD who are naïve to treatment. Moving forward, the 137 enrolled patients will be followed for the primary trial endpoint of height velocity at 12 months, along with safety and pharmacodynamics secondary endpoints. Versartis expects to present top-line results from the VELOCITY trial as soon as the third quarter of 2017.
“For more than three decades, recombinant human growth hormone has been effective to treat children, adolescents and adults with growth hormone deficiency, but the daily injection schedule is inconvenient and can be painful or distressing for children and their caregivers,” Alan D. Rogol, M.D., Ph.D., an endocrinologist and professor emeritus at the University of Virginia School of Medicine, stated in the news release. “Somavaratan may offer the least frequent dosing schedule with twice-monthly dosing, and with the Phase 3 VELOCITY trial now fully enrolled, it may be the first of the long-acting growth hormone preparations currently in development to become available for children with GHD.”
In addition to its phase III VELOCITY trial in the U.S., Versartis’s pediatric GHD clinical development program includes the J14VR5 trial, which is currently underway in Japan. Earlier this month, Versartis announced entry into an exclusive license and supply agreement with Teijin Limited regarding the development and commercialization of somavaratan in Japan. The J14VR5 trial is currently in phase II development, with the company forecasting a transition to phase III by the end of this year.
According to data from the National Organization for Rare Diseases (http://nnw.fm/TE5x5), prevalence and incidence data regarding GHD vary widely as a result of a lack of standard diagnostic criteria. However, a report titled ‘Diagnosis of Growth Hormone Deficiency in Childhood’ by Takara Stanley, M.D. (http://nnw.fm/q6Zrp) suggests that the prevalence of GHD is estimated at roughly one in 4,000 children.
The development pipeline of Versartis also includes trials evaluating somavaratan for the treatment of adult GHD. Top-line results from its ongoing phase II VITAL trial for this indication, which is underway in the U.S., Europe and Australia, are also expected by the end of this year.
Versartis currently retains global rights to somavaratan outside of its alliance with Teijin Limited in Japan.
For more information, visit www.Versartis.com
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