BG-12 Psoriasis Study Meets Primary Endpoint
Thursday April 7, 8:00 am ET
Oral Compound Also Being Studied for MS in Phase II Trial
CAMBRIDGE, Mass., SAN DIEGO & LUCERNE, Switzerland--(BUSINESS WIRE)--April 7, 2005--Biogen Idec (NASDAQ: BIIB - News) and Fumapharm AG today announced results from 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. The trial met the primary endpoint and 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.
"These data will be used to support a filing for market authorization in Germany this year," said Burt A. Adelman, M.D., Biogen Idec's Executive Vice President, 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."
The trial, conducted by Fumapharm, was a multicenter, double-blind, placebo-controlled Phase III study of 175 patients with moderate to severe psoriasis. Patients were randomized to receive placebo (n=70) or 720 mg of BG-12 a day (n=105) for 16 weeks. Patients were evaluated using the psoriasis area and severity index (PASI), a common measure of overall psoriasis severity. The primary endpoint was the PASI 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% for patients receiving BG-12 and 10% for patients receivingplacebo.
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. The data from the study will be presented at an upcoming medical meeting.
Biogen Idec also announced that a Phase II study of BG-12 in patients with relapsing-remitting multiple sclerosis (MS) was initiated in November 2004. The study, being conducted in Europe, is a placebo-controlled, dose-ranging study designed to assess the efficacy and safety profile of BG-12. The primary endpoint of the study will be an MRI measurement of the amount of brain lesion activity at six months. Approximately 250 patients are expected to be enrolled in the study across 10 countries.
About BG-12
In October 2003, Biogen Idec licensed exclusive worldwide rights to develop and market BG-12 from Fumapharm AG, a privately held pharmaceutical company headquartered in Lucerne, Switzerland. BG-12 is an oral fumarate derivative with an immunomodulatory mechanism of action. Biogen Idec is evaluating BG-12 in a range of diseases, including psoriasis and MS... |
