The Ministry of Health has approved research on a drug for the treatment of botulism

The drug was developed by the Center named after. Gamaleya (created the Sputnik V covid vaccine). it is capable of protecting patients from a lethal dose. The permit was issued against the backdrop of a massive incidence of botulism after eating salads with beans.

The Ministry of HEALTH issued permission to conduct clinical trials of a drug for the treatment of botulism, which was developed by the National Research Center for Epidemiology and Microbiology (NICEM) named after N.F. Gamaleya, the department said in a message received by RBC.

“The Russian Ministry of Health has issued permission for clinical trials of a new drug for neutralizing botulinum toxin A, developed by the NICEM. Gamaleya. This is a drug based on monoclonal antibodies that can bind toxin in the patient’s blood,” said Minister Mikhail Murashko .

Preclinical studies have already been carried out, they have shown good results in terms of safety and effectiveness, the department noted.

Botulism is an acute infectious disease. Manifests itself in the form of general infectious intoxication, damage to the gastrointestinal tract, and neurological syndromes. Symptoms also include severe fatigue, dizziness, weakness, dry mouth, blurred vision , vomiting, diarrhea and constipation.

The bacteria Clostridium botulinum, which is considered the causative agent of botulism, are obligate anaerobes and can reproduce only in conditions of complete absence of oxygen.

Pharmvestnik reported that the first phase of clinical trials of the drug is included in the state assignment for NICEM for the current year. It is planned that the research will take place in two stages and will be completed in 2025. The patent, registered in 2022, states that binding of the antibody to the toxin will protect against a lethal dose of botulinum toxin. Among the authors of the drug are the DIRECTOR of the Center named after. Gamaleya Alexander Ginzburg and his deputy Denis Logunov.

“As part of preclinical studies on animals, the ability of the drug to ensure 100% survival of animals during lethal intoxication with botulinum toxin type A was demonstrated. At the first stage of clinical trials, the safety of using our development in healthy volunteers will be assessed,” said the HEAD of the laboratory of immunobiotechnologies of the Research Center of Epidemiology and Microbiology. Gamaleya of the Ministry of Health of RUSSIA Dmitry Shcheblyakov.

In June, dozens of people in several Russian cities were hospitalized with signs of botulism after eating salads with canned beans from Kitchen on the District. On June 26, the Ministry of Health reported that 232 people who had botulism had been discharged from hospitals, and another 148 were being treated. One death is known - a 21-year-old resident of Kostroma, who became infected with botulism in Nizhny Novgorod and did not seek help immediately, but after returning to Kostroma.

In the case of the production and sale of products that do not meet safety requirements, the management of “Kitchen on the District” (Local Kitchen LLC) and the company producing beans “Savon-K” were placed under house arrest, and the cook of this company was arrested.