Use of Nanomanganese® for the prevention and treatment of patients with severe forms of Covid-19
Cytokine shock (also known as cytokine storm or cytokine release syndrome) refers to the phenomenon of abnormal, excessive and self-sustaining production of inflammatory cytokines in the body. This host immune response — induced by an inflammatory, systemic trigger — is deregulated, abnormally acute, inappropriate and harmful (generally fatal without appropriate treatment in intensive care).
Cytokine shock is the main cause of death from COVID-19.
Numerous publications show that in certain acute viral pathologies there is an inhibitory effect of the virus on the expression of manganese superoxide dismutase (MnSOD) allowing the virus to multiply in cells. This intracellular depletion of MnSOD promotes a runaway immune response and the onset of a storm of inflammatory cytokines. The lesions observed COVID-19-linked pneumonia are due first to the virus, then second to the inflammatory immune reaction in no adaptative response to the viral infection.
MnSOD removes reactive oxygen species (ROS) and therefore confers protection against cell death. Consequently, this protein plays an anti-apoptotic role against oxidative stress, ionizing radiation and inflammatory cytokines.
Medesis Pharma is developing a radiation-protection drug (NP02-NanoManganese®) for the treatment of people irradiated after a civil or military nuclear accident. The preclinical studies were carried out in collaboration with the Army Biomedical Research Institute (IRBA) in France.
A series of studies have been carried out on irradiated animals, with very favorable results allowing survival of all animals under LD50 irradiation.
There is a similarity in the major pulmonary inflammatory lesions observed in the two pathologies, one triggered by the COVID-2 coronavirus and the other by nuclear irradiation. They are linked to an excessive autoimmune reaction.
Phase II Clinical Development for Covid-19
A phase II clinical study of NanoManganese® treatment of severe forms of COVID-19 will be carried out in Brazil in seven Hospital Centers including 120 patients during their hospitalization (30 placebos and 90 treated).