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September 14, 2016

Roche reports positive results from phase three clinical development programme of OCREVUS

Swiss drug manufacturer Roche has reported positive results from its phase three clinical development programme of OCREVUS to treat two forms of multiple sclerosis (MS).

Swiss drug manufacturer Roche has reported positive results from its phase three clinical development programme of OCREVUS to treat two forms of multiple sclerosis (MS).

OCREVUS has been developed as a humanised monoclonal antibody that selectively targets CD20-positive B cells, fusing to CD20 cell surface proteins expressed on certain B cells while leaving stem cells or plasma cells, securing the key functions of the immune system.

CD20-positive B cell is a specific type of immune cell believed to be a contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

“Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS."

Nerve cell damage causes disability in people with MS.

Roche’s phase three clinical development programme for OCREVUS includes three studies, namely OPERA I, OPERA II and ORATORIO.

OPERA I and OPERA II are identically designed randomised, double-blind, double-dummy, global multi-centre studies intended to test the safety and efficacy of OCREVUS compared with Rebif involving 1,656 subjects with relapsing MS (RMS).

ORATORIO was designed as a phase three-randomised, double-blind, global multi-centre study to test the safety and efficacy of OCREVUS compared to a placebo involving 732 people with primary progressive MS (PPMS).

Post-hoc analysis of the studies suggested the efficacy of OCREVUS in controlling disease in patients with RMS and PPMS.

The analysis was based on the determination of two composite endpoints using a combination of clinical and MRI outcomes which are the no evidence of disease activity (NEDA) in patients with RMS and no evidence of progression (NEP) in patients with PPMS.

OPERA I and II studies scientific steering committee member and Barts and the London School of Medicine and Dentistry chair of neurology professor Gavin Giovannoni said: “Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS.

“These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS.”

NEDA analysis of phase three OPERA I and OPERA II studies exhibited increased number of patients achieving NEDA.

New post-hoc analysis of ORATORIO study based on NEP suggested no evidence of degradation of a person’s physical disability.

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