Findings from the Ocarina II (Phase III) study offer exciting perspectives for people with multiple sclerosis.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III study Ocarina IIaimed at evaluating ocrelizumab administered as a 10-minute subcutaneous injection twice a year, met the primary endpoint and secondary endpoints in patients with relapsing forms of multiple sclerosis or with primarily progressive multiple criminals (Smr o SMPP).
Subcutaneous injection of ocrelizumab was shown to be non-inferior to ocrelizumab administered via intravenous (IV) infusion based on pharmacokinetics (blood levels) at 12 weeks. Subcutaneous injection of ocrelizumab is also comparable to IV ocrelizumab in terms of efficacy on MRI (magnetic resonance imaging) parameters such as lesion reduction at 12 weeks. The safety profile of ocrelizumab subcutaneous injection is consistent with that of IV ocrelizumab
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The 10-minute injection of ocrelizumab was designed to be performed without the need for IV administration infrastructure and therefore could also be administered in MS centers with no IV infrastructure or limited capacity. Ocrelizumab sc maintains the same twice-yearly, twice-yearly dosing regimen of ocrelizumab to which multiple sclerosis patients treated with the drug have been shown to be largely adherent. This new sc delivery modality allows ocrelizumab administration to be tailored to the specific needs of patients and healthcare professionals.
“These findings offer people with multiple sclerosis the ability to obtain the breakthrough benefits of ocrelizumab in a way that is most appropriate for them, saving time and healthcare resources,” he said. Levi Garraway, MD, Ph.D., Chief Medical Officer and Head of Global Product Development at Roche –. This new subcutaneous injection will allow ocrelizumab to be delivered in 10 minutes twice a year, reducing the time people with MS spend treating their disease.”
Detailed trial results will be presented at an upcoming medical meeting and submitted for evaluation by health authorities around the world.
Roche is committed to developing innovative clinical research programs that enable a better understanding of multiple sclerosis, and which can help further reduce the progression of disability in SMR and PMS by optimizing the treatment experiences of those living with the disease .
The Ocarina II studio
Ocarina II is a phase III, international, multicenter, randomized study to evaluate the pharmacokinetics, safety, and efficacy of the subcutaneous formulation of ocrelizumab versus IV ocrelizumab in 236 patients with RMS or PMS. The primary endpoint is non-inferiority in serum Auc (area under the curve) predicted by a model from day 1 to 12 weeks after subcutaneous injection compared to IV infusion
Secondary endpoints include maximum serum ocrelizumab concentration (Cmax), total number of active T1-enhancing gadolinium-enhancing lesions detected at 8 and 12 weeks, total number of new or enlarging T2 lesions measured at 12 and 24 weeks, safety outcomes, immunogenicity and biomarker outcomes. Exploratory endpoints include patient reported outcomes (PROs).
The subcutaneous formulation of Ocrelizumab
The investigational subcutaneous formulation combines ocrelizumab with human hyaluronidase PH20, a drug delivery technology from Halozyme Therapeutics. Ocrelizumab is a humanized monoclonal antibody designed to target CD20-positive B lymphocytes, a specific type of immune cell thought to be a major contributor to damage to myelin (nerve cell insulation and support) and axon (nerve cell). .
In people with multiple sclerosis, damage to nerve cells can cause disability. Preclinical studies have shown that ocrelizumab binds to CD20 surface proteins expressed on some B lymphocytes, but not on stem or plasma cells, suggesting that some important immune system functions may be retained.
The delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronic acid – a glycosaminoglycan, a natural sugar chain present within the body – present in the space subcutaneous. These features increase the permeability of tissue under the skin, creating space for large molecules such as ocrelizumab to enter, and allow the subcutaneous formulation to be rapidly dispersed and absorbed into the bloodstream.
IV ocrelizumab is the first and only therapy approved for both SMR (including relapsing-remitting [Smrr] and secondary progressive MS [Smsp] active or relapsing, in addition to the clinically isolated syndrome [Cis] in the USA) and for the SMPP. IV ocrelizumab is given by intravenous infusion every six months. The initial dose is given as two 300 mg infusions two weeks apart. Subsequent doses are given as single 600 mg infusions.
Multiple sclerosis
Multiple sclerosis (MS) is a chronic disease affecting more than 2.8 million people worldwide. MS develops when the immune system abnormally attacks the insulating and supportive layer surrounding nerve cells (the myelin sheath) in the central nervous system (brain, spinal cord, and optic nerves), causing inflammation and the damage that it follows.
This damage can cause a wide range of symptoms, including muscle weakness, fatigue and vision problems, and can escalate to permanent disability. Most people with multiple sclerosis experience their first symptom between the ages of 20 and 40, making it the leading cause of nontraumatic disability in young adults.
People with any form of multiple sclerosis experience disease progression, i.e. permanent loss of nerve cells in the central nervous system, from the onset of the disease, even without obvious clinical symptoms or apparent worsening of them. Delays in diagnosis and treatment can adversely affect people with MS, in terms of physical and mental health, and contribute to the negative financial impact on the individual and on society.
An important goal in treating MS is to slow, halt and ideally prevent disease activity and progression as soon as possible.
Relapsing-remitting multiple sclerosis (RRMS) is the most common form of the disease and is characterized by episodes with new or worsening signs or symptoms (relapses), followed by periods of recovery. About 85% of people with MS are initially diagnosed with MS RR. In most people diagnosed with RRMS, it eventually progresses to secondary progressive MS (SPMS), marked by a steadily worsening disability over time.
Relapsing forms of MS (MSR) include people with PMS and people with PMS who go on to relapse. Primary progressive multiple sclerosis (MPPS) is a debilitating form of the disease characterized by steadily worsening symptoms, but usually without perceptible relapses or periods of remission, and is diagnosed in about 15% of people with MS. Prior to the Food and Drug Administration’s (FDA) approval of ocrelizumab, there were no FDA-approved treatments for PMS.
Nurse Times editorial team
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