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Versartis Inc. reports long-acting recombinant growth hormone extension trial data
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The 12-month results from an extension study looking at long-term safety and efficacy of a novel, long-acting form of recombinant human growth hormone (rhGH) developed by Versartis Inc. are encouraging, according to a press release.
The endocrine-focused biopharmaceutical company launched the trial for VRS-317, designed to treat pre-pubertal children with growth hormone deficiency (GHD), at the close of the Phase 1b/2a clinical trial in March.
“In the group of patients … who were moved from a weekly dose of 1.15 mg/kg in the Phase 2a trial to a semi-monthly dose of 3.5 mg/kg in the extension study, we saw an increase in IGF-I levels as predicted by our PK/PD model,” Jeffrey L. Cleland, PhD, CEO of Versartis Inc., said in the release.
Approximately 95% of patients who completed Phase 2a elected to enroll and continue treatment, according to the release. A subset of 20 patients who were receiving 1.15 mg/kg weekly were switched to 3.5 mg/kg semi-monthly.
With 3.5 mg/kg semi-monthly, patients reached a mean insulin-like growth factor-1 (IGF-1) standard deviation score (SDS) of 0.5, which is in the upper part of the therapeutic range, according to the release; it was almost an entire standard deviation higher than the mean IGF-1 SDS of -0.4 reached with 2.5 mg/kg semi-monthly. Increases in IGF-1 were achieved without overexposure to IGF-1.
Further, a subset of patients treated for 6 months at the higher dose showed a mean annualized height velocity increase of nearly two centimeters per year (7.5 cm/year in the first 6 months vs. 9.3 cm/year in the second 6 months).
The safety profile in all patients was comparable to daily growth hormone therapy, according to the release. No unexpected or serious adverse events were reported; the few events noted were mild and transient.
The 3.5 mg/kg semi-monthly dose, selected based on confirmation of the PK/PD model from the Phase 1b study, will be used in the upcoming randomized, open-label Phase 3 Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Study.