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news.Versartis, a biotechnology company developing therapeutics for the treatment of endocrine disorders, has reported long-term preclinical safety data for VRS-317, the company's proprietary once monthly form of recombinant human growth hormone (rhGH).
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Versartis develops new therapeutic proteins utilizing the proprietary Amunix half-life extension XTEN technology.
XTEN is a novel hydrophilic sequence of natural amino acids and is expressed as a fusion protein with a therapeutically active peptide or protein.
The study is a double-blind, placebo-controlled, single-ascending dose Phase 1 trial which enrolls up to 50 adult patients with growth hormone deficiency (GHD) in the US and Europe to evaluate the safety and tolerability of a single subcutaneous dose of VRS-317
Preclinical data have demonstrated that VRS-317 provides biological activity and safety to daily rhGH with a lower total monthly dose of rhGH and was used as the basis for the company’s ongoing Phase 1 clinical trial.
Versartis CEO Jeffrey Cleland said the data presented demonstrates in monkeys that dosing every two weeks for three months was well-tolerated, and further supports the development of VRS-317 as the first once monthly treatment for growth hormone deficiency in both adults and children.