ALX-0141 Phase I study is a double-blind, placebo-controlled study designed to assess safety, tolerability and PK of a subcutaneous injection of ALX- 0141.
The 120 days follow-up of the trial showed positive safety data as well as data on the pharmacokinetics (PK) of ALX- 0141.
Additionally, serum levels of certain bone biomarkers were measured to provide an early indication of efficacy.
In the trial, ALX-0141 was administered in 6 dose levels as a single subcutaneous injection ranging from 0.003mg/kg to 1mg/kg.
Ablynx said that due to the unexpectedly long period of suppression of CTX-1 in a large proportion of the subjects, the follow-up interval of the study has been prolonged and the results of the final PD, safety and immunogenicity analyses are anticipated to be published during the first half of 2011.
The study period has been extended to allow for all subjects to be followed until their biomarker values return to the baseline level because at present, less than 20% of the subjects have shown normalisation of the lead biomarker level, indicative of the long-lasting biological activity of ALX- 0141.