A randomised, double blind, placebo controlled efficacy and safety trial of different doses/dose regimens of FP187 compared to placebo in moderate to severe plaque psoriasis.
Forward Pharma, A/S through its wholly owned German subsidiary Forward Pharma GmbH, today announced initiation of its first phase II trial investigating efficacy and safety of different doses and regimes of FP187 in a double blind, placebo controlled trial.
The trial is running in 18 centers in Germany and is foreseen to include at least 180 patients with moderate to severe plaque psoriasis. This study will compare the efficacy and safety of different doses and dose regimens of FP187 on the proportion of patients achieving PASI 75 (reduction in the PASI score of 75% from baseline), and several other secondary endpoints including Quality of Life. The Company expects data to be available Q3, 2011.
FP187 is an oral small molecule that demonstrated promising pharmacokinetics and good tolerability in Phase I testing in healthy volunteers. Following scientific advice meetings with the German Heath Authorities (BfArM), Forward Pharma GmbH received approval from the agency and ethics committees in August, 2010 for the current Phase II study.
Forward Pharma A/S is a privately held biotech company headquartered in Copenhagen, Denmark with an operational subsidiary in the BioCity campus of Leipzig, Germany.