Ascendis Pharma A/S (NASDAQ:ASND) released topline results from Phase 3 foresiGHt trial to compare the efficacy and safety of TransCon hGH (lonapegsomatropin) with placebo and daily hGH (human growth hormone, somatropin) in adults with growth hormone deficiency (GHD).
The foresiGHt Trial evaluated 259 adults with GHD aged 23 to 80 years old.
TransCon hGH demonstrated superiority on its primary efficacy endpoint at Week 38:
- Change from baseline in trunk percent fat as measured by dual x-ray absorptiometry (TransCon hGH -1.67% vs. placebo +0.37%, LS mean difference = -2.04%, p < 0.0001)
TransCon hGH demonstrated superiority on its key secondary efficacy endpoints at Week 38:
- Change from baseline in total body lean mass (TransCon hGH +1.60 kg vs placebo
- -0.10 kg, LS mean difference = 1.70 kg, p < 0.0001)
- Change from baseline in trunk fat mass (TransCon hGH -0.48 kg vs. placebo +0.22 kg, LS mean difference = -0.70 kg, p = 0.0053)
Exploratory post-hoc analysis at Week 38 demonstrated comparable treatment effects of TransCon hGH and daily hGH on target tissues. For patients with IGF-1 SDS levels ≤ 1.75 at Week 38:
- Change from baseline in trunk percent fat (TransCon hGH -2.42% vs. daily hGH -2.59%)
- Change from baseline in total body lean mass (TransCon hGH +1.70 kg vs daily hGH +1.37 kg)
- Change from baseline in trunk fat mass (TransCon hGH -0.90 kg vs daily hGH -0.94 kg)
TransCon hGH was generally safe and well tolerated, with no discontinuations related to the study drug and with comparable safety and tolerability to daily hGH.
The company plans to submit a supplemental Biologics License Application to the FDA for the adult GHD indication next year and looks forward to reporting data from the Phase 2 program in Turner syndrome.
Price Action: ASND shares are up 1.15% at $122.28 on the last check Tuesday.
