Biogen Idec received a much-needed boost yesterday after revealing that moderate-to-severe psoriasis patients receiving its investigational compound, known as BG-12, in a Phase III clinical trial saw a statistically significant improvement in their symptoms versus those treated with placebo.
The trial, which was carried out by German company, Fumapharm, included 175 patients with moderate to severe psoriasis who received either placebo or 720mg of BG-12 a day for 16 weeks. Patients were evaluated using the psoriasis area and severity index, a common measure of overall psoriasis severity. At 16 weeks, the median PASI was 5.8 for the BG-12 group and 14.2 for the placebo group, which correlates to a 68% reduction in PASI score for the BG-12 group, versus a 10% reduction for the placebo receivers.
The biotechnology company, which was hit earlier this year after suspending sales of its much anticipated multiple sclerosis drug, Tysabri (natalizumab) [[01/03/05a]], says that these data will form the basis of a filing for marketing authorization in Germany. Additional Phase III studies will need to be conducted for applications in the US and the rest of Europe.
Biogen Idec is evaluating BG-12 in a range of diseases, including psoriasis and MS. A Phase II trial in patients with relapsing-remitting MS is currently in the recruitment phase.