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.