The phase III study was designed to evaluate the efficacy and safety of the oral fumarate in the treatment of moderate to severe psoriasis. The trial met the primary endpoint and patients receiving BG-12 demonstrated a statistically significant clinical improvement after 16 weeks of treatment compared to patients receiving placebo.
The trial, conducted by Fumapharm, evaluated patients using the psoriasis area and severity index (PASI), 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. Median percentage reduction from baseline PASI was 68% for patients receiving BG-12 and 10% for patients receiving placebo.
In the study, the most commonly reported adverse events were flushing and diarrhea. In addition, one patient was hospitalized for pneumonia and one patient was hospitalized for kidney stones.
“These data will be used to support a filing for market authorization in Germany this year,” said Dr Burt Adelman, Biogen Idec’s executive vice president of development. “We will work with our partner, Fumapharm, to determine the next steps for the BG-12 program. Additional phase III studies would need to be conducted for applications in the US and the rest of Europe.”
Biogen Idec also announced that a phase II study of BG-12 in patients with relapsing-remitting multiple sclerosis, an area of recent trouble for the company, was initiated in November 2004. The study, being conducted in Europe, is designed to assess the efficacy and safety profile of BG-12 and is expected to enroll approximately 250 patients.