Roche’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS - Seite 3

About the subcutaneous formulation of OCREVUS (ocrelizumab)
The investigational subcutaneous (SC) formulation combines OCREVUS with Halozyme Therapeutics’ Enhanze drug delivery technology.

OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.

The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the SC space. This increases the permeability of the tissue under the skin, allowing space for large molecules like OCREVUS to enter, and enables the SC formulation to be rapidly dispersed and absorbed into the bloodstream.

OCREVUS IV is the first and only therapy approved for both RMS (including relapsing-remitting MS [RRMS] and active, or relapsing secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. OCREVUS IV is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

About the OCARINA II study
OCARINA II (NCT05232825) is a Phase III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and radiological and clinical effects of the subcutaneous (SC) formulation of OCREVUS compared with OCREVUS intravenous (IV) infusion in 236 patients with relapsing MS (RMS) or primary progressive MS (PPMS). Initial results shared at ECTRIMS-ACTRIMS 2023 demonstrated that the trial met the primary endpoint of non-inferiority in area under the serum concentration time curve (AUC) from day 1 to 12 weeks after SC injection compared to IV infusion. Secondary endpoints include maximum serum concentration (Cmax) of OCREVUS, the total number of active, gadolinium-enhancing T1 lesions at 8 and 12 weeks, and new or enlarging T2 lesions at 12 and 24 weeks, as well as safety and immunogenicity outcomes. Exploratory endpoints include patient-reported outcomes.