A Phase III study designed to evaluate the efficacy and safety of BG-12, an oral fumarate, in the treatment of moderate to severe psoriasis, met the primary endpoint.
The patients receiving BG-12 demonstrated a statistically significant clinical improvement as measured by a lower median psoriasis severity score after 16 weeks of treatment than patients receiving placebo.
The trial was a multicenter, double-blind, placebo-controlled Phase III study of 175 patients with moderate to severe psoriasis.
Patients were randomized to receive 720 mg of BG-12 a day (n=105 ) or placebo ( n=70 ) for 16 weeks.
The primary endpoint was the PASI ( Psoriasis Area Severity Index ) score at 16 weeks.
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 percent for patients receiving BG-12 and 10 percent 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.
BG-12 is an oral fumarate derivative with an immunomodulatory mechanism of action.
Fumaric acid esters ( FAEs ) have been used for the oral treatment of psoriasis since 1959 and have been registered for this indication in Germany since 1994.
Source: Biogen Idec, 2005