The Italian Medicines Agency, the country’s pharmaceutical regulatory authority, has authorised a clinical trial for the use of an existing osteoporosis drug in COVID-19 patients with mild symptoms caused by the SARS-CoV-2 virus. The trial will be run by the EU-funded EXSCALATE4CoV project. The drug in question is raloxifene, which is mainly used to prevent and treat osteoporosis in postmenopausal women. In May 2020, project partners Dompé Pharmaceuticals, Fraunhofer Institute and the University of Leuven filed a patent on its use as a treatment for COVID-19.
Testing osteoporosis drug’s safety and efficacy
In the trial, up to 450 participants will receive a 7-day treatment of either raloxifene or placebo capsules. The study will assess how safely and efficiently raloxifene prevents the replication of the SARS-CoV-2 virus in cells. It will be conducted at the National Institute for Infectious Diseases Lazzaro Spallanzani in Rome, and also involves the Humanitas Research Hospital in Milan. Plans are under way to also extend the trial to other centres in Italy and abroad. “The clinical trial marks the completion of the first phase of the Exscalate4CoV project which has screened 400,000 compounds (already approved drugs and natural products which are safe in humans) and specifically tested 7,000 molecules in vitro,” states the latest press release published on the website of project coordinator Dompé Pharmaceuticals. “So far, all data generated by E4C (10 peer reviewed articles and 10 additional articles submitted), the evidence from over 20,000 in vitro experiments as well as a virtual model of the sars-CoV-2 [sic] virus, have been made openly available to the international scientific community through the portal.”
Supercomputers in the fight against the coronavirus
The results so far have been made possible by the combined use of Europe’s supercomputing resources and top life science research labs. At the heart of the project is Exscalate (EXaSCale smArt pLatform Against paThogEns), currently the world’s most powerful and cost-efficient intelligent supercomputing platform. According to the press release, “Exscalate leverages a chemical library of 500 billion molecules, applying a processing capacity of more than 3 million molecules per second. E4C’s screening process is supported by massive supercomputing resources for more than 100 Petaflops from four major EU machines: Cineca’s Marconi - 150 Petaflops; ENI’s HPC5 - 51,7 Petaflops, and Barcelona Supercomputing Center’s MareNostrum4 -13.7 Petaflops, Julich’s Juwels - 7 Petaflops …” This makes it possible to perform a screening process in weeks rather than the years traditional techniques would require. The EXSCALATE4CoV (EXaSCale smArt pLatform Against paThogEns for Corona Virus) project team has identified another two safe-in-human drugs that could be repurposed for treating COVID-19 patients. These drugs will be further characterised and validated to ensure their efficacy as potential COVID-19 treatments before the partners go on to design new clinical trials. For more information, please see: EXSCALATE4CoV project website
EXSCALATE4CoV, raloxifene, coronavirus, COVID-19, supercomputing