MILAN (Reuters) – Italian biotech company Dompe said it received the consent from Brazil’s medical regulator to start Stage II human trials of among its items being established for organ transplants for treating badly ill COVID-19 patients.
The Stage II medical trial is focused on examining efficacy and security of Dompe’s Reparixin in hospitalised adult patients with serious COVID-19 and will sign up 48 clients, the privately owned business said in a statement on Tuesday.
The study, authorised in May by Italy’s medications firm, includes a minimum of 10 centres in the Brazilian states of Sao Paulo, Bahia, Minas Gerais, Santa Catarina and the Federal District, Dompe said.
The company plans to expand the research study at Stage III phase to the United States, it stated. It will register 111 clients.
Dompe started testing Reparixin, an active ingredient under development to make drugs in oncology and transplant, on extensive care clients in Italy in May. But it needed to suspend the trial due to the lack of clients in extreme condition, a spokesperson for Dompe said.
He added that the 5 Italians who were administered the drug at that time have actually now completely recovered.
Brazil has the world’s second most significant break out of COVID-19 after the United States.
Reparixin prevents the action of interleukin 8 (IL-8), one of the inflammatory signalling proteins that is thought to be connected with the lung injury seen in patients with SARS-CoV2 infection, Dompe said in a separate declaration.
Subsequently, this action is possibly useful in the treatment of COVID-19 pneumonia clients, where the immune action might result in vascular permeability that hampers gas exchange and oxygenation, it stated.
Dompe is headquartered in Milan, with more than 800 staff members around the world and workplaces in the United States.
Reporting by Emilio Parodi; Modifying by Josephine Mason and Mark Heinrich
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