Versartis (VSAR) Announces Presentation of Somavaratan Data at 17th ICE in Beijing
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Versartis, Inc. (Nasdaq: VSAR) announced that data on efficacy, safety (including metabolic parameters), and treatment adherence from up to 30 months of somavaratan treatment in the pediatric long-term safety study (now named VISTA), were presented during the 17th International Congress of Endocrinology, being held August 31 to September 4, 2016, in Beijing. Highlights from the three oral presentations include:
- Safety profile was maintained at 30 months of dosing
- HbA1c levels were stable overall during the treatment period
- Bone age advanced in line with height velocity over two years of treatment
- Treatment adherence rate was 99.6% after 24 months of at-home dosing and over 2200 doses at the current Phase 3 dose
Somavaratan (VRS-317) Treatment for Pediatric Growth Hormone Deficiency (GHD): Results at 2.5 Years:
Eric Humphriss, Vice President of Global Clinical Operations at Versartis, and Will Charlton MD, MAS, FAAP, Senior Medical Director at Versartis, detailed efficacy and safety results from the Phase 2a clinical trial of somavaratan in treatment-naive, pre-pubertal GHD children (months 0-6 of treatment) and the subsequent VISTA study (Versartis Long-Term Safety Study of Somavaratan). As reported previously, the somavaratan dose increased during the VISTA study to 3.5 mg/kg of somavaratan twice-monthly (the dose currently being evaluated in Phase 3) and 57 subjects were evaluable in the Year 2 analysis at this dose level. After dose increase, mean height velocity (HV) was comparable from Years 1 to 2 (8.1±2.2 vs. 7.8±2.3 cm/year) and mean height SDS continued to improve (-2.1±0.6 vs. -1.6±0.7). Catch up growth over the 2 year period was supported by mean bone age (BA) advancing by 2.4 years and mean height age by 2.7 years. The difference in mean years between chronological age and BA decreased over the course of the study: 1.5±0.8 at screening, 1.4±0.9 at Year 1, and 1.0±1.0 at Year 2. The frequency of Adverse Events (AEs) declined substantially after the initial 6 month exposure period, and in the 48 patients evaluable in months 24-30 no new types of AEs were reported. Results of this study through 30 months suggest that the Phase 3 dose regimen was safe and well tolerated and produced Year 2 HV comparable to NCGS database estimates of rhGH daily dosing in the US.
HbA1c over Two Years of Treatment with Somavaratan (VRS-317) in Children with Growth Hormone Deficiency (GHD):
The effects of long-acting rhGH preparations on metabolic status have not been well-characterized, although the risk of development of diabetes mellitus (DM) in children treated with rhGH is considered minimal. Dr. Charlton described efforts to characterize whether treatment of GHD children with somavaratan may have effects on their glucose metabolism as measured by HbA1c. HbA1c was measured in the VISTA study at months 6, 18, and 30 of treatment exposure with somavaratan. Mean HbA1c was 5.2±0.31% at 6 months (n=59), 5.3±0.33% at 18 months (n=56), and 5.3±0.29% at 30 months (n=45). A minority of individual subjects showed minor changes in HbA1c over time. No changes in mean HbA1c were observed with increased exposure to somavaratan, and no subjects developed DM. Overall, somavaratan did not elicit meaningful effects on insulin sensitivity as assessed by HbA1c in pre-pubertal GHD children.
Treatment Adherence with Weekly, Twice-Monthly and Monthly Dosing of Somavaratan (VRS-317), a Long-Acting Growth Hormone Treatment for Children with Growth Hormone Deficiency (GHD), After 24 Months of At-Home Dosing:
Mr. Humphriss presented updated data on treatment adherence following 24 months of at-home dosing in the VISTA study of somavaratan. Treatment adherence was recorded by caregivers using an electronic patient-reported outcome diary (eDiary; Bracket, Inc.). Following 24 months of at-home dosing and over 2200 doses at the current Phase 3 dose, treatment adherence rate was 99.6%-- identical to the result at 18 months. These data suggest that a twice-monthly dosing regimen has the potential to improve treatment adherence and associated outcomes, as an estimated 66%–77% of adults and children with GHD are noncompliant with daily rhGH injections, and this has been associated with reduced annual height velocity.
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