Generics
Italy's regulatory body clears trial of osteoporosis drug to treat COVID-19
27 October 2020 -

The main medical regulator in Italy gave the go-ahead on 27 October 2020 for human clinical trials on raloxifene, a generic osteoporosis drug that researchers hope may also help reduce COVID-19 symptoms and make patients less infectious, Reuters news agency reported on Tuesday.

Raloxifene has been identified as a potential COVID-19 treatment by researchers using supercomputers to screen over 400,000 molecules for chemical characteristics that might inhibit the virus, focusing on those already approved for use in humans.

This trial will involve 450 hospital and home patients at Rome's Spallanzani Hospital and Humanitas in Milan in the initial phase.

Volunteers will be given a seven-day treatment of raloxifene capsules in a randomised sample and 174 more people may be added in the final stage. Enrolment will last 12 weeks.

Andrea Beccari, from Excalate4Cov, a public-private consortium led by Italy's Dompé Farmaceutici, said researchers hoped that raloxifene, a generic drug known as a selective oestrogen receptor modulator, would block replication of the virus in cells and thus slow down progress of the disease.

Marco Allegretti, head of research at Dompé Farmaceutici, was quoted as saying: "It inhibits virus replication, thus preventing the worsening of patients with mild symptoms, and also decreases infectivity, limiting the viral load."

The Excalate4Cov platform is backed by the European Commission and coordinates supercomputing centres in Italy, Germany and Spain with pharmaceutical companies and research centres, including the University of Louvain, Fraunhofer Institut, Politecnico di Milano and Spallanzani Hospital.

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