Biocad Multiple Sclerosis Therapy Drug BCD-132

Main article: Multiple sclerosis

The preparation with the code BCD-132 is a humanized monoclonal antibody with a modified glycosylation profile, having specificity to the CD20 antigen on the surface of B lymphocytes.

2021: Permission of the Ministry of Health of the Russian Federation to conduct the final phase of clinical research BCD-132

Biotechnology company Biocad April 22, 2021 announced the receipt of permission from the Ministry of Health of the Russian Federation to conduct the third (final) phase of clinical studies of the original drug for the treatment of multiple sclerosis. In the course of phase I and II studies, he showed high effectiveness: the number of exacerbations decreased in patients and the manifestations of the disease decreased. In addition, according to the study scheme, the drug is administered every six months, which can increase patients' adherence to such treatment. The results of phase III will allow the start of the registration procedure for the drug, its entry into the market is expected within five years.

The treatment of multiple sclerosis (MS) is one of the pressing problems of modern practical neurology. It is a chronic autoimmune disease in which the myelin sheath of the nerve fibers of the brain and spinal cord is affected and degenerative changes occur in the central nervous system. MS can lead to disorders of motor activity, paresis, decreased intelligence and complete paralysis. People of young and middle age (15-40 years old) are most likely to suffer from the disease. According to the Atlas of the International Federation of MS Patients, in the world about 2.8 million people live with this diagnosis, and in recent years their number has been growing.

The disease proceeds wavily: exacerbations are replaced by periods of remission. In areas where antibodies more aggressively attack the myelin membrane and more foci appear, various clinical manifestations of the disease arise: paresis, paralysis of the limbs, and the functions of internal organs can be impaired. After exacerbation, functions are restored, but not always completely, and each time lesions can become more serious and eventually lead to disability.

Development of Biocad, a drug with the code BCD-132, is a humanized monoclonal antibody with a modified glycosylation profile, having specificity for the CD20 antigen on the surface of B lymphocytes. The drug is used to treat MS due to its ability to bind to CD20-positive cells, which play a key role in the course of the disease.

In multiple sclerosis, an unknown breakdown occurs in the body, and their own antibodies begin to work against their own healthy tissues - the myelin sheath of the nerves, "explained Yulia Linkova, director of the clinical development department of Biocad. According to the results of therapy with this drug, patients significantly reduce the number of brain demyelination foci according to MRI and significantly reduce the number of exacerbations. These results allow us to confidently go into the third phase of clinical research, the main goal of which is to stop the progression of disability and achieve an improvement in the quality of life of patients.

The drug was studied as part of a phase I and II clinical study in MS patients with exacerbations. Pharmacokinetic and pharmacodynamic parameters that showed rapid and prolonged depletion of the target B cell pool were evaluated. According to the results of six months of therapy, the phase II study proved the superiority of the drug over placebo and its no less effectiveness compared to the comparative drug (teriflunomide). According to the dynamics of key brain MRI parameters and clinical indicators, patients showed a significant decrease in the activity of the demyelinating process in the brain and a decrease in the number of exacerbations. Studies have also shown that the drug is well tolerated by patients. The findings provided an optimal therapeutic dose of BCD-132 for further study.

The successful results of the phase I and II clinical study allowed us to reach the final phase III - BCD-132-4/Mirantibus. It will be attended by at least 336 patients with MS with exacerbations. Measures of efficacy and safety of the drug against similar measures in patients receiving the comparison drug will be studied in greater depth. After that, the process of registering the drug for further use in medical practice will be launched.

As of April 2021, there is no radical treatment for multiple sclerosis, but to varying degrees, effective methods of therapy with drugs that change the course of multiple sclerosis (PITRS) have been developed. They help reduce the number of exacerbations or even reduce them to zero by controlling immunoaggression and reducing the rate of disability of the patient, which without the use of these drugs can come very quickly.

Some earlier generations of PITRS suggest intramuscular injections of drugs for life with administration almost a day later. In addition, many drugs of an interferon nature can entail undesirable reactions with improper administration (bruises and other local manifestations) and can cause a flu-like syndrome, an increase in temperature. Patients' quality of life is deteriorating, including due to such exhausting therapy, and patients can arrange so-called "drug holidays," which provoke more frequent exacerbations. The presented drug involves administration once every six months, which can potentially increase the adherence to therapy and the quality of life of patients with MS.