Bradley Miller, MD, University of Minnesota Academic Health Center hopes the team learns â€œgood informationâ€ about how kids are growing on this dose of somavaratan that will then be confirmed in the phase 3 head-to-head with growth hormone daily.
At ENDO 2017, Bradley Miller, MD, University of Minnesota Academic Health Center, discussed the findings from phase 2 and extension trial data for VRS-317 (somavaratan/Versartis, Inc.), a long-acting growth hormone treatment for kids with growth hormone deficiency (GHD). This will only be able to be administered twice monthly. The phase 3 trial is expected to end in the fall.
Miller hopes they learn “good information” about how kids are growing on this dose that will then be confirmed in the phase 3 head-to-head with growth hormone daily.
Previously, in the phase 1 trial, the doses given were 5mg/1kg/month given weekly, twice a month, or monthly. That was used to select the 2.5mg/1kg twice a month, and then by a year into the trial it was 3.5mg/1kg twice per month — that’s the dose that’s actually going into phase 3, and for which they have the most data for both safety and efficacy.
The kids receiving growth hormone for GHD (at least in the trials) started as young as age 3 (they did have some children with GHD as infants who need growth hormone from the very beginning). Most kids finish around 15 for girls and 17 for boys. At that point some kids are still going to be GHD as adults, and they’ll need retesting to see if this is something they’re going to have to take for their whole life. That’s a small percentage of children, but some of them need it long term, Miller said.
According to Miller, having a long-acting product will be crucial for families, specifically improving compliance. He explained that families are often shocked when told that the children have to take a shot every day. Furthermore, when they looked at compliance for kids on growth hormone daily, the estimates ranged everywhere from missing half of the shots to three-fourths of the shots. Miller also believed it would improve how the kids grow just because they’re getting more of their growth hormone consistently.
Miller also said there has been a small number of adverse events, primarily injection site-related events. “Except for pain complaint, you couldn’t see anything. There wasn’t lipoatrophy, there wasn’t redness, and there wasn’t irritation.” According to Miller, these weren’t adverse events different from those seen in other children with growth hormone treatment. “So, it’s nothing that we wouldn’t expect.”