Genentech and Biogen Idec announce positive results from ocrelizumab phase II RRMS study

Oct 15 2010

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (NASDAQ:BIIB) today announced 24-week results from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease. Ocrelizumab demonstrated a significant reduction in disease activity as measured by brain lesions and relapse rate. Patients with RRMS suffer from relapses and disabling symptoms caused by nerve damage which can significantly affect their quality of life.

“These efficacy results are amongst the most remarkable seen in a phase II RRMS study, and show that ocrelizumab may have the potential to offer benefits to patients with this disease”

Reductions in total number of brain lesions detected by magnetic resonance imaging (MRI) scans (the primary endpoint of the study) were highly significant at 96% for 2000mg ocrelizumab and 89% for 600mg ocrelizumab compared to placebo. Disease activity was also measured by reduction in annualized relapse rate (ARR), the rate of attacks or flare-ups per patient-year. At week 24, ARR was significantly lowered versus placebo with a reduction of 73% for ocrelizumab 2000mg and 80% for ocrelizumab 600mg.

"These efficacy results are amongst the most remarkable seen in a phase II RRMS study, and show that ocrelizumab may have the potential to offer benefits to patients with this disease," said Professor Ludwig Kappos, lead investigator of the study, from the Department of Neurology, University Hospital Basel, Switzerland.

"We are strongly encouraged by these data and the possibility that ocrelizumab could become a new option for patients with MS," commented Hal Barron, M.D., executive vice president, Product Development and chief medical officer. "We believe in the potential of ocrelizumab and look forward to exploring it further in the final phase of clinical development."

Both ocrelizumab doses were generally well tolerated and no opportunistic infections were reported. Serious adverse events (SAEs) were similar in all treatment groups. Infusion-related events during first infusion, predominantly mild to moderate, were more common with ocrelizumab (34.5% and 43.6%) than placebo (9.3%). However, these reports decreased during the second ocrelizumab infusion and were comparable to those initially reported with placebo.