MILAN, Sept 1 (Reuters) - Italian biotech firm Dompe said it received the go-ahead from Brazil's medical regulator to start Phase II human trials of one of its products being developed for organ transplants for treating severely ill COVID-19 patients.
The Phase II clinical trial is aimed at evaluating efficacy and safety of Dompe's Reparixin in hospitalised adult patients with severe COVID-19 and will sign up 48 patients, the privately owned company said in a statement on Tuesday.
The study, authorised in May by Italy's medicines agency, involves at least 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 study at Phase III stage to the United States, it said. It will enroll 111 patients.
Dompe started testing Reparixin, an active ingredient under development to make drugs in oncology and transplantation, on intensive care patients in Italy in May. But it had to suspend the trial due to the lack of patients in severe condition, a spokesman for Dompe said.
He added that the five Italians who were administered the drug at that time have now fully recovered.
Brazil has the world's second biggest outbreak of COVID-19 after the United States.
Reparixin inhibits the action of interleukin 8 (IL-8), one of the inflammatory signalling proteins that is thought to be associated with the lung injury seen in patients with SARS-CoV2 infection, Dompe said in a separate statement.
Consequently, this action is potentially useful in the treatment of COVID-19 pneumonia patients, where the immune response may result in vascular permeability that impedes gas exchange and oxygenation, it said.
Dompe is headquartered in Milan, with more than 800 employees worldwide and offices in the United States. (Reporting by Emilio Parodi Editing by Josephine Mason and Mark Heinrich)
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