Ascendis announces Phase II results for ACP-001
Ascendis Pharma A/S (NASDAQ:ASND) announced top-line results from a Phase II study of TransCon Growth Hormone ( ACP-001) to treat growth hormone deficiency (GHD). The study's primary endpoints were related to pharmacokinetics and safety; Ascendis was unable to confirm whether it met all five. The therapy was also comparable to Genotropin somatropin in increasing height velocity, a secondary endpoint.
The 53-patient, six-month study compared weekly 0.14, 0.21 and 0.30 mg/kg doses of TransCon Growth Hormone to 0.21 mg/kg/week Genotropin administered daily in pre-pubertal children with GHD. Ascendis said there were no drug-related serious adverse events, and blood concentrations of human growth hormone (hGH) were comparable between equivalent weekly doses of the hormones. ...