October 21, 2011 / 6:00 AM / 9 years ago

Full Biogen DEFINE data shows robust results

* Final DEFINE results consistent with initial data

* Results presented on Friday at ECTRIMS

* Investors now eye second trial, CONFIRM

By Toni Clarke

Oct 21 (Reuters) - Full data from a late-stage clinical trial of Biogen Idec Inc’s experimental multiple sclerosis drug, BG-12, showed robust results across multiple measures.

Earlier this year the company released initial data from a Phase III trial known as DEFINE that showed the drug, when given twice a day, cut the annualized relapse rate by 53 percent at two years compared with placebo, and cut the rate of disability progression by 38 percent.

Full data from the trial of 1,237 patients was presented on Friday at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showed the drug reduced the risk of relapse by 49 percent in patients who took the drug twice a day and 50 percent in patients who took it three times a day.

“BG-12 may be a valuable treatment option for MS patients, combining strong efficacy, a favorable safety profile and oral administration,” said Dr. Ralf Gold, a trial investigator and professor at St. Josef-Hospital/Ruhr-University in Bochum, Germany. “Preclinical research has shown that BG-12 has anti-inflammatory and neuroprotective effects.”

Gold said that if the clinical responses seen in DEFINE are replicated later this year in a second late-stage trial known as CONFIRM, then “BG-12 has the potential to provide a new approach to treating MS and be an important step forward for patients.”

Magnetic resonance imaging (MRI) scans showed that at two years, patients receiving BG-12 experienced significant reduction in the number of brain lesions compared to patients on placebo.

Adverse reactions were reported by about 95 percent of patients, whether in the placebo group or treatment group. The most frequently reported events were flushing, MS relapse, nasopharyngitis, headache, diarrhea and fatigue. There were no deaths related to study treatment. There was no increase in infections, serious infections, opportunistic infections or malignancies, data showed.

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