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FDA AUTHORIZES PH3 CLINICAL TRIALS FOR COVID-19 THERAPEUTIC CARRIMYCIN

Updated: Jan 14

Source : https://rtmagazine.com/products-treatment/pharmaceuticals/intl-pharmaceuticals/fda-authorizes-ph3-clinical-trials-for-covid-19-therapeutic-carrimycin/


Dec 24, 2020 | Clinical Trials |Posted by RT Staff


Carrimycin has become the world’s first synthetic biological drug treatment for severe COVID-19 to receive US FDA approval for Phase III trials, according to its developer, the Tonglian Group. Testing has already shown that Carrimycin is effective in treating patients who have been hospitalized with severe COVID-19 symptoms, helping them recover within 14 days from the worst impacts of coronavirus.


Carrimycin includes anti-viral, anti-inflammatory and anti-fibrosis effects in addition to the anti-bacterial effect. It was originally designed to treat community-acquired infections in adults caused by sensitive bacteria. According to the company, laboratory tests in early 2020 showed it has a strong anti-coronavirus effect, inhibiting the replication of 2019-nCoV in cells, without causing significant side effects. The Phase III trials are building on testing carried out in China, the results of which have been recognized by the FDA.


Jiang Enhong, CEO of the Tonglian Group said, “This is a major breakthrough in the treatment of COVID-19, based on international collaboration. The availability of vaccines is, of course, very important. But we know there will always be people who contract COVID, which is why it is so essential we have therapeutic treatments, particularly for anyone hospitalized with a serious case of COVID-19.”


Carrimycin’s FDA-approved international multi-centre Phase III trial will start in January 2021 and will run for six months. It will be conducted in the US, Argentina, Brazil, Colombia, India, Mexico, Peru, Philippines and Ukraine. However, the locations could be adjusted as the pandemic evolves. The trial will involve 300 patients, half in the experimental group and half in the control group.


Jiang Enhong continued, “What is new is that Carrimycin is anti-viral, combined with the standard antibiotic bacterial treatment, and anti-inflammatory and anti-fibrosis effects. And that is what makes it such a potent treatment against COVID-19. It is a single medicine that avoids the drug interactions of combined treatments with single therapeutic effects.


“We hope Carrimycin will be able to help people all over the world to recover quickly from the worst symptoms of COVID-19. 2020 has been dominated by the impact of the pandemic. In 2021, we’ll be talking about using science to minimize the impact, whether that’s therapeutic treatments, vaccines or restricting infection rates.”


According to the company, patients take two Carrimycin tablets a day; the medication is stored at room temperature. The course is 14 days for severe cases and around seven days for moderate cases. A seven-day course currently costs USD $5,355, the company reports.


Posted by RT Staff

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