Pharma Focus Europe

Positive Phase III Results Revealed for Roche's OCREVUS (Ocrelizumab): Twice-yearly, 10-minute Subcutaneous Injections in Multiple Sclerosis Patients

Friday, July 14, 2023

Roche, a pharmaceutical company, has announced positive results from a recent clinical trial known as OCARINA II. The trial investigated the use of OCREVUS® (ocrelizumab) as a subcutaneous injection for the treatment of multiple sclerosis (MS). The study included patients with relapsing forms of MS or primary progressive MS. The results showed that the subcutaneous injection of OCREVUS, administered twice a year in a 10-minute procedure, achieved its primary and secondary goals.

The trial demonstrated that the subcutaneous injection of OCREVUS was as effective as the intravenous infusion in terms of pharmacokinetics (blood levels) over a period of 12 weeks. Moreover, the subcutaneous injection was comparable to the intravenous infusion in controlling magnetic resonance imaging (MRI) lesion activity in the brain over the same 12-week period. The safety profile of the subcutaneous injection was consistent with that of the intravenous infusion.

One of the key advantages of the OCREVUS subcutaneous injection is that it does not require infrastructure for intravenous administration. This feature has the potential to expand the usage of OCREVUS in MS centers that lack intravenous infrastructure or have limitations in intravenous capacity. Additionally, the subcutaneous injection maintains the twice-yearly dosing regimen of the intravenous infusion, which has been shown to promote high persistence and adherence among MS patients.

The detailed results of the OCARINA II trial will be presented at an upcoming medical meeting and submitted to health authorities worldwide. Roche remains committed to advancing innovative clinical research programs that contribute to a better understanding of MS, reduce disability progression, and enhance the treatment experience for individuals living with the disease.

OCREVUS is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell believed to play a significant role in the damage to myelin (nerve cell insulation and support) and axons (nerve cells) in MS. By binding to CD20 cell surface proteins expressed on B cells, OCREVUS aims to preserve important functions of the immune system while mitigating nerve cell damage.

The investigational subcutaneous formulation of OCREVUS combines the drug with Halozyme Therapeutics' Enhanze® drug delivery technology. This technology utilizes a proprietary enzyme called recombinant human hyaluronidase PH20 (rHuPH20) to temporarily degrade hyaluronan, a chain of natural sugars in the body, thereby increasing tissue permeability in the subcutaneous space. This enables the rapid dispersion and absorption of the subcutaneous formulation into the bloodstream.

OCREVUS is the first and only therapy approved for both relapsing forms of MS (including relapsing-remitting MS [RRMS], active, or relapsing secondary progressive MS [SPMS], and clinically isolated syndrome [CIS] in the United States) and primary progressive MS (PPMS). The intravenous infusion of OCREVUS is administered every six months, with an initial dose of two 300 mg infusions given two weeks apart, followed by single 600 mg infusions in subsequent doses.

Multiple sclerosis is a chronic disease that affects over 2.8 million people worldwide. It occurs when the immune system mistakenly attacks the myelin sheath, the protective covering of nerve cells in the central nervous system (including the brain, spinal cord, and optic nerves), leading to inflammation and damage. MS can cause a wide range of symptoms, such as muscle weakness, fatigue, and visual difficulties, and may eventually result in disability. It is the leading cause of non-traumatic disability in younger adults, with most individuals experiencing their first symptoms between the ages of 20 and 40.

Treating MS aims to slow, halt, or prevent disease activity and progression as early as possible to minimize the physical, mental, and financial impact on individuals and society. The most common form of the disease is relapsing-remitting MS (RRMS), characterized by episodes of new or worsening symptoms followed by periods of recovery. Over time, the majority of individuals diagnosed with RRMS will transition to secondary progressive MS (SPMS), which involves a steady worsening of disability. Primary progressive MS (PPMS) is a debilitating form of the disease, marked by gradually worsening symptoms without distinct relapses or remission periods. Prior to the approval of OCREVUS, there were no FDA-approved treatments available for PPMS.

Roche is actively engaged in neuroscience research and development, focusing on developing innovative treatments for various neurological disorders, including MS. Through collaborations and partnerships, the company aims to advance scientific understanding and address the significant challenges faced by individuals with neurological conditions.

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