South Korean and European Union research institutions signed a letter of intent (LOI) for international joint research on COVID-19 treatment

- Exchange of clinical and nonclinical trial information on COVID-19 treatment incorporating raloxifene

- Joint research initiated through bilateral conference proposal by EU

- GBSA, NIH, KISTI, Dompé Farmaceutici, and CINECA to participate

The South Korean province of Gyeonggi anticipates “accelerated development of a COVID-19 treatment through sharing and cooperation”

Korean and the European Union funded research institutions have agreed to undertake joint research on a COVID-19 treatment utilizing raloxifene, a medication approved to treat osteoporosis and now is under development for COVID-19.

Gyeonggi Province announced that the provincial administration and the Gyeonggido Business and Science Accelerator (GBSA) had signed an LOI and confidentiality agreement on the joint development of a COVID-19 treatment with Dompé farmaceutici the coordinator of the Exscalate4Cov [1], an EU-funded supercomputer-based COVID-19 treatment development research project and CINECA, the Italian national supercomputing center and partner of the Exscalate4CoV project.

On the South Korean side, government-funded research organizations including the GBSA, the National Institute of Health (NIH), and the Korea Institute of Science and Technology Information (KISTI), which is developing COVID-19 treatments using supercomputers, are slated to participate in the research.

This agreement was first suggested by the European side, which has made advances in COVID-19 development program using raloxifene. On June 15, the GBSA had announced the results of a joint study with the Korea Disease Control and Prevention Agency (KDCA) that confirmed the suppressive effects of raloxifene on the COVID-19 virus.

Under the agreement, Gyeonggi Province and the participating organizations on both sides facilitate the exchange of information pertaining to non-clinical and clinical trial plans as well as characteristics of raloxifene and COVID-19 antiviral materials revealed through supercomputer analysis.

Meanwhile, Dompé Farmaceutici is reportedly advocating first-phase clinical trials, calling for the participation of 450 subjects in Italy (and under submission in other European Countries) in a program to monitor safety and treatment effects over a 12-week period seven days after the administration of raloxifene and a placebo. In early October, the GBSA submitted a raloxifene clinical trial research plan to the Korean Ministry of Food and Drug Safety, with the Ajou University Medical Center serving as an organizer in conjunction with other participants including the Gyeonggi Provincial Medical Center/Korea University Ansan Hospital.

There is hope that raloxifene would work against the replication of the virus in the human body and thus slow down progress of the disease. "In preclinical studies, raloxifene showed to inhibit the replication of the virus thus could prevent worsening of symptoms in mild patients, and potentially decreasee infectivity, limiting the viral load. This will be evaluated during the clinical trial in patients." said Marcello Allegretti, head of Research at Dompé farmaceutici.

An official from the South Korean province said, “With this agreement, research on raloxifene, which was being studied in Korea and Europe, will proceed under a cooperative system. Through sharing and cooperation, we will accelerate the development of a COVID-19 treatment and contribute to an earlier end of the global pandemic.”

It is important to remark that there is no evidence so far of a positive benefit/risk ratio of the molecule in rating Sars-CoV-2 infections in humans, nor on the dosage to be used. For these reasons, raloxifene is not authorized for use in this indication outside of a clinical study.

[1] The Exscalate4Cov (www.exscalate4cov.eu) consortium, supported by the the EU’s Horizon 2020 programme for research and innovation, is coordinated by Dompé farmaceutici, and composed by 18 member institutions from seven European countries: Politecnico di Milano (Dept. of Electronics, Information and Bioengineering), Consorzio Interuniversitario CINECA (Supercomputing Innovation and Applications), Università degli Studi di Milano (Department of Pharmaceutical Sciences), International Institute of Molecular and Cell Biology in Warsaw (Warsaw, Poland), KU Leuven, Elettra Sincrotrone Trieste, Fraunhofer Institute for Molecular Biology and Applied Ecology, BSC Barcelona Supercomputing Centre, Forschungszentrum Jülich, Università Federico II di Napoli, Università degli Studi di Cagliari, SIB Swiss Institute of Bioinformatics, KTH Royal Institute of Technology (Department of Applied Physics), Associazione Big Data, Istituto Nazionale di Fisica Nucleare (INFN), Istituto nazionale per le malattie infettive Lazzaro Spallanzani and Chelonia Applied Science.- https://www.exscalate4cov.eu/consortium.html

E4C’s League of associated parties includes: ENI, Alfasigma, CFEL Center for Free-Electron Laser Science, MMV Medicines for Malaria Ventures, Esteve Pharmaceutical, University of Basel Biozentrum, University of Basel Innovation Office, University of Basel Department of Pharmaceutical Sciences, D-wave, Pierre fabre, Greenpharma, University of Sheffield - Sheffield Institute for Translational Neuroscience – SITraN, Dassault Systemes- Biovia, Institute of Food Science Research, CECAM Centre Européen de Calcul Atomique et Moleculaire, Nanome, Esteco, IT4Innovation, Università degli Studi della Tuscia, Sofia University “St. Kl. Ohridski”, Faculty of Physics, Institut Cochin- https://www.exscalate4cov.eu/league.html