Biogen Idec and Fumapharm AG today announced results from a Phase II study of BG-12, an oral fumarate, in patients with severe psoriasis.
Patients who received BG-12 in the trial showed greater improvement in their psoriasis than patients receiving placebo.
The results were presented today at the spring symposium of the European Academy of Dermatology and Venereology (EADV) in Budapest, Hungary.
Burt A. Adelman, M.D., Biogen Idec's Executive Vice President, Development said, "It is encouraging that 42% of patients receiving the highest dose of BG-12 achieved at least a 75% improvement in their Psoriasis Area and Severity Index (PASI) after 12 weeks, as compared to 11% of patients receiving placebo.
We look forward to reviewing the results of the ongoing Phase III trial in Europe and enhancing Biogen Idec's dermatology franchise." The trial, conducted by Fumapharm, was a multicenter, double-blind, placebo-controlled, dose-ranging Phase II study of 144 patients with severe forms of psoriasis.
Patients were equally randomized within four treatment groups and received either placebo or BG-12 at one of three different doses (120 mg, 360 mg, or 720 mg per day) for 12 weeks. Patients were evaluated using the PASI score, a common measure of overall psoriasis severity.
Some patients began improving as early as two weeks after the drug was administered. The key analysis was the PASI score at 12 weeks. Hans Peter Strebel, Ph.D., President and CEO of Fumapharm said, "Our partnership with Biogen Idec positions us well to jointly develop this promising approach to treating psoriasis." Other Phase II study details include:
- At week 12, median percentage reductions from baseline PASI were 71% for patients receiving 720 mg, 52% for patients receiving 360 mg, 31% for patients receiving 120 mg and 6% for patients receiving placebo.
- At week 12, 42% of patients in the 720 mg dose group achieved PASI 75, as compared to 11% of placebo patients.
PASI 75 represents a reduction of the PASI score of at least 75% from baseline measurement. The most commonly reported adverse events were flushing, elevations in liver function tests and common colds, which were generally transient and mild to moderate in severity.
In September 2003, Biogen Idec licensed certain exclusive rights to develop and market BG-12 from Fumapharm. Biogen Idec development plans for BG-12 include a range of autoimmune and inflammatory diseases, such as psoriasis and multiple sclerosis.