Medesis Pharma S.A.

Regulatory Filings • Feb 7, 2022

INCLUSION OF FIRST PATIENTS IN CLINICAL TRIAL IN BRAZIL ON NANOMANGANESE FOR THE TREATMENT OF SEVERE FORMS OF COVID-19

Montpellier, February 07, 2022 at 5:45 p.m. - Medesis Pharma (ISIN: FR0010844464, MNEMO: ALMDP), a pharmaceutical biotechnology company developing drug candidates with Aonys, its proprietary technology for the delivery of active ingredients in nano micelles by buccal route, announces the inclusion of the first patients in the phase 2 clinical trial ongoing in Brazil with its drug candidate NanoManganese for the treatment of severe forms of COVID-19.

120 patients will be included in this study carried out in 8 Hospital Centers in Brazil. Treatment with NanoManganese is initiated in hospitalized patients positive for COVID-19. The objective is to quickly improve respiratory symptoms triggered by the SARS-Cov-2 virus, avoiding acute respiratory distress syndrome, evolution towards intensive care and associated complications. The study is double blinded with 90 treated patients and 30 placebos.

NanoManganese associates Aonys® technology with manganese ion, delivering intracellularly manganese at cation state. Manganese Superoxydismutase (MnSOD) is key in mechanisms eliminating intracellular free radicals and has a regulatory role in the immune system. Several studies (Tanaka 2017, Semrau 1998, Dalpke 2003) have shown that certain viruses produce autoantibodies directed against MnSOD, inhibiting the enzyme causing an immune system runaway and aggravation of tissue damage, particularly in the lungs. NanoManganese, through its MnSOD-like activity, is thought to balance oxidative stress and downregulate cytokine storm, thus limiting complications observed in patients with severe forms of COVID-19.

The number of cases of COVID-19 in Brazil has increased since the beginning of 2022. The need to find treatments that can limit serious forms of the infection remains a priority. The results of this clinical study should be known during the summer of 2022. Confirmation of the benefit of NanoManganese in this patient population would be a key milestone in the development program of NanoManganese for the treatment of severe forms of aggressive viral diseases (such as COVID-19 or seasonal influenza, etc.…).