the company Genentech, Belonging to the Roche group, reported on September 27 that the Phase III clinical trial of the investigational drug Ocrelizumab was successful.
this medicine manages to delay the progression of progressive multiple sclerosis (MS) by at least 12 weeks, At its beginnings. This multiple sclerosis (MS) subtype, which affects approximately 10 to 15% of the population with this disease, is a very aggressive disease. To date, he has had no cure or treatment, but this multicenter (international) study with the Spanish participation, has shown the effectiveness of this drug which could become the first and the only therapeutic option for patients with this disease. disease.
Until now there was no treatment for EMM
The study of this drug is called Oratorio and was carried out by the head of the clinical neuroimmunology service of the Vall d’Hebron hospital and director of the Multiple Sclerosis Center of Catalonia (CEMCAT), Xavier Montalbán. This study examined the efficacy of the drug Ocrelizumab in 732 patients with progressive primary multiple sclerosis and the main conclusion is that it succeeds in slowing down, at least 12 weeks, the progression of the handicap caused by the disease.
Montalbán wanted to celebrate the discovery and said:
“This is a truly historic moment. It is the first time that a drug has been shown to be effective in controlling this type of neurological disease. It opens a window towards better knowledge and better treatment of multiple sclerosis.”
This medicine is a monoclonal antibody designed to selectively attack CD20B + cells which are believed to play a key role in the destruction of myelin and nerves, causing the symptoms of multiple sclerosis. By binding to the surface of these proteins, Ocrelizumab helps preserve the most important functions of the immune system.
What is multiple sclerosis?
the multiple sclerosis (MS) is a neuroinflammatory disease that it affects the central nervous system (CNS), both the brain and the spinal cord. It is not known exactly what causes MS, but it damages myelin, a substance that forms the membrane that surrounds nerve fibers (axons) and helps conduction of electrical impulses between them.
Myelin is destroyed in several areas, sometimes leaving scars (sclerosis). These injured areas are also known as demyelination plaques. By destroying the substance myelin, the ability of the nerves to conduct electrical impulses to and from the brain is disrupted, causing symptoms such as:
- Vision alterations
- muscular weakness
- Coordination and balance issues
- Sensations such as numbness, itching, or tingling
- Thinking and memory problems
Multiple sclerosis it affects women more than men. Its onset usually occurs between the ages of 20 and 40, although cases have also been reported in children and the elderly. The disease is usually mild, but in more severe cases some people lose the ability to write, speak or walk.
In most cases, this disease progresses to epidemics, but in primary progressive multiple sclerosis the disability worsens continuously and slowly over months or years, so it is considered a severe form of this condition.
Phases of clinical development of a drug
For a drug to be sold, it must go through a process of evaluating its efficacy and safety, thus avoiding endangering the lives of those who will take it. The development of a new drug is long and difficult because only two or three out of 10,000 pharmacological substances come onto the market.
When the drug has been sufficiently evaluated in in vitro models and in animal studies (preclinical phase), research in humans begins, called clinical trials. Conventionally, the period of clinical development of a pharmaceutical product is divided into 4 consecutive phases, but which can overlap. Here are the phases that are part of the clinical trial:
- Phase I: This phase includes the first studies carried out in humans, the main objective is to measure the harmlessness and tolerability of the compost. Given the level of risk involved, the number of volunteers is low and the duration of the phase short.
- Phase II: The risk at this stage is moderate and its objective is to provide preliminary information on the efficacy of the product and to establish the dose-response relationship. Hundreds of subjects are needed and this phase can last several months or even years.
- phase III: This is the phase in which this medicinal product is located, and it is necessary to evaluate its effectiveness and its tolerance under normal conditions of use and with regard to the therapeutic alternatives available for the indication studied. Therefore, its use in combination with other drugs is tested for several months or years, during which the degree of incidence of desired and unwanted effects is analyzed. These are confirmatory therapeutic studies.
- Phase IV: It is performed after the drug has been placed on the market to study it again in a clinical context, and to provide more information about its side effects.
Following the positive results of phase III of the Ocrelizumab clinical trial, At the beginning of next year, a European authorization will be requested to be able to market this drug.. It usually takes about six months. Therefore, each country will decide whether or not to authorize the sale on its territory.