A phase II clinical trial can begin immediately for clofazimine, which is a drug approved by the Food and Drug Administration on the World Health Organization’s List of Essential Medicines.
No Jolla, Kalev. – March 16, 2021 – Prof. Temperate nature A study authored by scientists at the Sanford Burnham Prebis Institute of Medical Discovery and the University of Hong Kong showed that clofazimine, approved by the FDA and included in the World Health Organization’s List of Essential Medicines, exhibits potent antiviral activities against SARS-CoV-2 and inhibits response. Exaggerated Inflammation Associated with Severe COVID-19. Based on these results, a phase 2 study evaluating clofazimine as a home treatment for COVID-19 could begin immediately.
“Clofazimine is an ideal candidate for treating COVID-19. Senior co-author Sumit Chanda, Ph.D., professor and director of the Immunology and Disease Program at Sanford Burnham Prebys, says it is safe, affordable, easy to make, taken in pill form and can be made universally available. We hope to test clofazimine. In phase 2 clinical trials as soon as possible for people who have tested positive for COVID-19 but have not been admitted to hospital.As there is currently no outpatient treatment for these individuals, clofazimine may help reduce the effect of the disease, which is especially important now that we see the types. New virus appears, and the current vaccines against it appear to be less effective. ”
Detect a promising candidate by examining the drug library
Clofazimine was initially identified by examining one of the largest groups of drugs known in the world for its ability to prevent the recurrence of SARS-CoV-2. The Chanda team has previously reported on Temperate nature Clofazimine was one of 21 effective drugs in the laboratory, or in a laboratory dish, in concentrations likely to be safely achieved in patients.
In this study, researchers tested clofazimine in hamsters – an animal model of COVID-19 – that had been infected with SARS-CoV-2. Scientists have found that clofazimine reduces the amount of virus in the lungs, including when given to healthy animals prior to infection (prophylactically). The drug also reduced lung damage and prevented a “cytokine storm,” which is an overwhelming inflammatory response to SARS-CoV-2 that could be deadly.
“Animals that received clofazimine experienced less lung damage and less viral load, especially when receiving the drug prior to infection,” says co-senior author Rin Sun, Ph.D., professor at the University of Hong Kong and distinguished professor emeritus at the University of Hong Kong. University of California, Los Angeles (UCLA). “Besides inhibiting the virus, there are indications that the drug is also regulating the host’s response to the virus, providing better control of infection and inflammation.”
Clofazimine also worked synergistically with remdesivir, which is the current standard treatment of care for people hospitalized with COVID-19, when given to hamsters infected with SARS-CoV-2. These results indicate a potential opportunity to expand the availability of remdesivir, which is costly and in limited supply.
How does clofazimine work?
The study showed that clofazimine stops SARS-CoV-2 infection in two ways: blocking its entry into cells and disrupting RNA replication (SARS-CoV-2 RNA is used for replication). Clofazimine was able to reduce the replication of the Coronavirus, which causes Middle East Respiratory Syndrome (MERS), in human lung tissue.
“More importantly, clofazimine appears to contain comprehensive coronavirus activity, indicating that it could be an important weapon against future epidemics,” says senior co-author Kwok Young Yueen, head of the Department of Infectious Diseases at the University of Hong Kong. Corona virus, which causes severe acute respiratory syndrome (SARS), has been discovered. “Our study indicates that we should consider creating a stock of ready-made clofazimine that can be deployed immediately in the event that another novel coronavirus emerges.”
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In July 2020, Summit Chanda shared more about his team’s race to find a cure for COVID-19.
In-office test for clofazimine
A phase two trial to evaluate clofazimine in combination with interferon beta 1b as treatment for people with COVID-19 hospitalized is underway at the University of Hong Kong. Interferon beta-1b is an injection-administered immune regulator and is currently used to treat people with multiple sclerosis.
“Our data indicate that clofazimine should also be tested as the only treatment for people with COVID-19, which reduces many of the barriers to treatment,” says Chanda. “People with COVID-19 will simply be able to receive a regimen of low-cost pills, rather than travel to the hospital to receive injections.”
Old medicine finds new purpose
Clofazimine was discovered in 1954 and is used to treat leprosy. Its promise in treating COVID-19 is discovered through high-throughput screening of more than 12,000 drugs from the drug library ReFRAME – one of the most comprehensive groups of compounds approved by the Food and Drug Administration for other diseases or tested extensively for safety Human. ReFRAME was created by Calibr, Scripps Research’s drug discovery division, with support from the Bill & Melinda Gates Foundation, with the goal of reusing existing drugs to meet unmet clinical needs.
Study co-authors and study participants are Sumit Chanda of Sanford Burnham Pribes. Ren Sun from the University of Hong Kong and University of California Los Angeles; And Kwok-Yung Yuen from the University of Hong Kong. The study’s first authors are Shuofeng Yuan, Xiangzhi Meng, Jasper Fuk-Woo Chan, and Zi-Wei Ye of the University of Hong Kong. And Xin Yin of the Sanford Burnham Prebys, who contributed equally to the study.
Additional study authors include Laura Reva, Lars Bachi, Noko Matsunaga and Yuan Bo of Sanford Burnham Prebes. Chris Chun Yu-chan, Bok Man Lay, Chris Chung Seng Chan, Vincent Kwok Man Bun, Andrew Chuck Yue Lee, Chun Kit Yuen, Jianli Kao, Rongwei Liang, Kaeming Tang, Wan Shu, Chit-ying Lau and Ko-Yung Sit and Wing-Kuk Au, Runming Wang, Kong-Hung Sze, Anna Jinxia Zhang, Hin Chu, Kin-Hang Kok, Ivan Fan-Ngai Hung, Ronald Adolphus Li, Honglin Chen, Hongzhe Sun, Dong-Yan Jin of the University of Hong Kong. Yu Yuan Zhang, Yan Dongtang and Shui Hui Kai from the Chinese Academy of Agricultural Sciences; Thomas Mandel Clausen and Jessica Biel of the University of California San Diego (UCSD) and University of Copenhagen; Jontaek Oh, Dong Wang, and Geoffrey De Esco from the University of California, San Francisco; Li Sheng from the University of Hong Kong and University of California Los Angeles; Yoshin Do from the University of California.
The study’s DOI is 10.1038 / s41586-021-03431-4.
The research featured in this press release was supported by the National Institutes of Health (NIH) (U19AI118610, U19AI135972, U19AI142733), Department of Defense (Department of Defense) (W81XWH-20-1-0270), Defense Advanced Research Projects Agency (HR0011- 19- 2-0020), Center of Excellence for Influenza Research and Monitoring (HHSN272201400008C), JPB Foundation, Open Philanthropy Project (2020-215611 (5384)), University of Hong Kong, National Key Research and Development Programs in China (2020YFA0707500), 2020YFA0707504), Richard Yu And Carol Yu, Chu Hong Kong Foundation, Michael Sik Kan Tong, Mai Tam Mak Mi Yin, Hui Ming, Hui Hui and Chau Sen, Lan Charitable Fund Limited, Chan Yin Chuen Memorial Charity Foundation, Marina Man Wai Li, Microbiology Research Fund South China Affiliated to Hainan Hong Kong Trade Association, Jesse and George Hu Charitable Foundation, Perfect Ship Medical Ltd., Kai Chung Tung, Fu Oei Corporation Ltd., Tse Kam Ming, Lawrence, Norman and Cecilia Yip, Dinah Roch, Suzanne and James Blair Foundation.
About the University of Hong Kong
Founded in 1911, the University of Hong Kong (HKU) is the oldest university institution in Hong Kong. The University of Hong Kong achieves impact through internationalization, innovation and interdisciplinary. Attracts and nurtures world-class scholars through excellence in research, teaching, learning and knowledge sharing.
About Sanford Burnham Prebis Medical Discovery Institute
Sanford Burnham Prebys is a prominent, independent biomedical research institute dedicated to understanding human biology and disease and advancing scientific discoveries to deeply affect human health. For more than 40 years, our research has produced breakthroughs in cancer, neuroscience, immunology, and pediatric disease, anchored in the National Cancer Institute designated cancer center and advanced drug discovery capabilities. For more information, visit us on SBPdiscovery.org or on Facebook at facebook.com/SBPdiscovery and on Twitter. Embed a Tweet.