Versartis has reported positive results from its clinical study of VRS-317, the company's once-monthly form of recombinant human growth hormone (rhGH).
The 60-day, double-blind, randomised, placebo-controlled, single-ascending dose Phase I trial was designed to evaluate the safety and tolerability of a single subcutaneous (SC) dose of VRS-317.
Versartis chief executive officer Jeffrey Cleland said; "We are very pleased with the recent clinical results observed in adults with GHD, and believe that the opportunity to present these findings to the paediatric endocrinology community is further evidence of the important potential that exists for VRS-317 to address the needs of patients with GHD."
The results demonstrated that the single doses of VRS-317 were safe and well tolerated while adverse events that were considered drug related were primarily mild and transient.
The SAEs, unexpected AEs, injection site lipoatrophy and significant post-dosing changes for fasting glucose, post-prandial glucose or fasting insulin were not reported.
Substantial reductions in cholesterol, triglycerides and LDL were observed in GHD patients receiving 0.80mg/kg VRS-317, which was rapidly absorbed, achieving a Tmax 2-3 days after a single SC dose, according to the company.
The PD profile of VRS-317 indicated that IGF-1 was normalised in a dose-dependent manner with the duration of IGF-1 normalisation increasing with dose, thereby allowing up to once monthly dosing for future trials.