The objective of the trial is to measure the safety and tolerability of hGH-CTP and to assess dose ranging and dose response.
The trial is enrolling up to 56 growth hormone deficient adults allocated among several dosing cohorts.
The interim results of the trial suggest that a single weekly injection of hGH-CTP in growth hormone deficient adults has the potential to maintain IGF-1 levels within this target range for at least seven days, thereby potentially enabling these patients to replace their current regimen of seven consecutive daily injections of hGH with a single injection of hGH-CTP.
Prolor Biotech expects to complete this Phase II trial around mid-year.
Prolor Biotech CEO Avri Havron said based on these promising interim data, they are increasingly confident that the Phase II trial will provide sufficient information to enable their researchers to establish the most suitable doses of hGH-CTP for their planned Phase III registration trial in adults with growth hormone deficiency.