A Phase 2 Trial Of Long-Acting TranCon Growth Hormone In Adult GH Deficiency
TransCon growth hormone is a sustained release human growth hormone prodrug in development in which unmodified growth hormone is transiently linked to a carrier molecule.
It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency.
This was a multi-center, randomized, open-label, active-controlled trial designed to compare the safety (including tolerability and immunogenicity), pharmacokinetics, and pharmacodynamics of three doses of weekly TransCon GH to daily growth hormone (Omnitrope).
Thirty-seven adult males or females diagnosed with adult growth hormone deficiency and stable on growth hormone replacement therapy for at least 3 months were, following a wash-out period, randomized (regardless of their pre-study dose) to one of three TransCon GH doses (0.02, 0.04, 0.08 mg GH/kg/week) or Omnitrope 0.04 mg GH/kg/week (divided into 7 equal daily doses) for 4 weeks.
Main outcomes evaluated were adverse events, immunogenicity, and growth hormone and insulin-like growth factor 1 levels.
TransCon GH was well tolerated; fatigue and headache were the most frequent drug-related adverse events and reported in all groups.
No lipoatrophy or nodule formation was reported. No treatment-emergent anti-growth hormone binding antibodies were detected.
TransCon GH demonstrated a linear, dose-dependent increase in growth hormone exposure without substantial accumulation.
Growth hormone maximum serum concentration and insulin-like growth factor 1 exposure were similar following TransCon GH or Omnitrope administered at comparable doses.
The results suggest that long-acting TransCon GH has a profile similar to daily growth hormone but with a more convenient dosing regimen. These findings support further TransCon GH development.
Hoybye C, Pfeiffer AF, Ferone D, et al. A phase 2 trial of long-acting TransCon growth hormone in adult GH deficiency. Endocr Connect. http://www.endocrineconnections.com/content/early/2017/02/14/EC-17-0007
TransCon growth hormone is a sustained release human growth hormone prodrug in development in which unmodified growth hormone is transiently linked to a carrier molecule.
It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency.
This was a multi-center, randomized, open-label, active-controlled trial designed to compare the safety (including tolerability and immunogenicity), pharmacokinetics, and pharmacodynamics of three doses of weekly TransCon GH to daily growth hormone (Omnitrope).
Thirty-seven adult males or females diagnosed with adult growth hormone deficiency and stable on growth hormone replacement therapy for at least 3 months were, following a wash-out period, randomized (regardless of their pre-study dose) to one of three TransCon GH doses (0.02, 0.04, 0.08 mg GH/kg/week) or Omnitrope 0.04 mg GH/kg/week (divided into 7 equal daily doses) for 4 weeks.
Main outcomes evaluated were adverse events, immunogenicity, and growth hormone and insulin-like growth factor 1 levels.
TransCon GH was well tolerated; fatigue and headache were the most frequent drug-related adverse events and reported in all groups.
No lipoatrophy or nodule formation was reported. No treatment-emergent anti-growth hormone binding antibodies were detected.
TransCon GH demonstrated a linear, dose-dependent increase in growth hormone exposure without substantial accumulation.
Growth hormone maximum serum concentration and insulin-like growth factor 1 exposure were similar following TransCon GH or Omnitrope administered at comparable doses.
The results suggest that long-acting TransCon GH has a profile similar to daily growth hormone but with a more convenient dosing regimen. These findings support further TransCon GH development.
Hoybye C, Pfeiffer AF, Ferone D, et al. A phase 2 trial of long-acting TransCon growth hormone in adult GH deficiency. Endocr Connect. http://www.endocrineconnections.com/content/early/2017/02/14/EC-17-0007
