The Nearmedic group of companies is preparing to produce the pharmaceutical substance of the new original anti-tuberculosis drug Makozinone. The drug was developed by Nearmedic group and the Swiss company École Polytechnique Fédérale de Lausanne (EPFL) together with the Innovative Medicines for Tuberculosis (Im4TB) international foundation.
«There is a constant growth of drug-resistant forms of tuberculosis in the world, so the international scientific community is faced with the task of finding and developing new medicinal forms against this disease. To date, Makozinone is one of the most promising among already existing anti-tuberculosis drugs and those being developed in the world. It has a unique mechanism of action and allows the use of combined therapy regimens of drug-resistant forms of tuberculosis. We are proud that, with the participation of our team, such a significant international project will be implemented in Russia,» said Vladimir Nesterenko, head of the Nearmedic group.
In the near future, the site of high-tech full cycle production of the original Makozinone (PBTZ 169) pharmaceutical substance will be fully ready to launch the new production at the industrial site of the Nearmedic Pharma LLC research and production facility in Obninsk.
The candidate anti-TB drug Makozinone has passed a number of studies in Russia and the countries of the European Union, proving its safety and effectiveness against TB strains with multiple and broad drug resistance. Research has been conducted since 2014. At the moment, the full cycle of preclinical studies and a series of Phase I clinical studies on healthy volunteers have been completed, as well as Phase II clinical studies — early bactericidal activity — to study the effectiveness and safety of the drug Makozinone when used in patients with newly diagnosed respiratory tuberculosis.
The development of the original pharmaceutical substance PBTZ 169 took many years. Back in 2014, the scientific director of the project, Professor Stuart Cole, presented the PBTZ 169 compound as a promising candidate for creating a new unique combination in modern tuberculosis therapy. In the same year, an exclusive license agreement was signed between EPFL (Switzerland), Im4TB international foundation (Switzerland) and the Nearmedic Group.
The published research results provide data proving a unique opportunity to increase the effectiveness of combined use of Makozinone with currently existing standard and novelty (Bedakvelin) anti-TB drugs, compared to their activity as mono-components. This is the most important criterion of the current strategy of the World Health Organization (WHO) for the introduction of new combined treatment regimens for tuberculosis, especially of its drug-resistant forms.
In October 2018, WHO, based on research results, assigned the pharmaceutical substance PBTZ 169 its international non-proprietary name Macozinone.