Raloxifene COVID-19 Clinical Trial in Sight...Gyeonggi Province Submits Plan to MFDS

[Suwon Ilbo=Park No-hun Reporter] Clinical trials for 'raloxifene,' an osteoporosis treatment drug confirmed to be effective in suppressing the COVID-19 virus, are entering the final countdown.

Gyeonggi Province and the Gyeonggi Institute of Science and Technology Promotion (GISTP) announced on the 8th that they have submitted a clinical trial plan to the Ministry of Food and Drug Safety (MFDS) for exploring the COVID-19 therapeutic effects of raloxifene, an osteoporosis treatment drug.

The Gyeonggi Province COVID-19 Clinical Research Council, launched in April, initiated the establishment of a clinical trial plan to develop raloxifene as a COVID-19 treatment drug with Ajou University Medical Center at the center, and with the participation of Gyeonggi Provincial Medical Center and Korea University Ansan Hospital. Subsequently, the clinical trial plan was finally completed after undergoing in vivo testing and data supplementation processes.

Upon notification of the MFDS opinion by this month, clinical research including patient recruitment is scheduled to begin in early November, and clinical trial results are expected to be released by the end of December.
This clinical trial is an exploratory investigator-initiated clinical study targeting approximately 100 inpatients at Gyeonggi Provincial Medical Center and patients in isolation at treatment centers, where the efficacy of raloxifene will be comprehensively evaluated by quantifying improvements in clinical symptoms and virus reduction rates.

Gyeonggi Province noted that since raloxifene is included as a key candidate drug in the 'Korea-EU Joint International Research Program for Developing COVID-19 Therapeutics' being pursued by GISTP together with the European Union, the sharing of preclinical and clinical trial results between Gyeonggi Province and Europe could significantly accelerate therapeutic approval.

Jung Gwi-wan, Senior Researcher at GISTP, stated, "Raloxifene demonstrates positive in vivo test results, blocking cellular infection of the virus through various mechanisms of action and showing lung damage inhibition effects in COVID-19-infected animals," and expressed optimism, saying, "We hope that raloxifene, which is inexpensive, safe, and effective, will succeed in clinical trials and contribute to ending COVID-19."

Heo Jung-yeon, professor at Ajou University Medical Center and principal investigator of this clinical trial, said, "It is particularly significant that we are about to conduct full-scale clinical trials using a candidate drug discovered by Gyeonggi Province at a time when cluster infections continue to occur primarily in the Seoul metropolitan area," adding, "We will do our best to present a Korean-developed therapeutic as soon as possible."

Meanwhile, GISTP announced research results in June through joint research with the Korea National Institute of Health, showing that raloxifene has COVID-19 virus inhibitory activity at the cellular level, as confirmed through the joint study to clarify COVID-19 virus suppression activity.