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FDA approves Phase III trial of synthetic biological COVID-19 treatment

Source :https://www.europeanpharmaceuticalreview.com/news/138938/fda-approves-phase-iii-trial-of-synthetic-biological-covid-19-treatment/


Jan 04, 2020 | By Hannah Balfour (European Pharmaceutical Review)


The international Phase III trial will evaluate whether a 14 day course of carrimycin can improve outcomes for COVID-19 patients with severe symptoms.




The US Food and Drug Administration (FDA) has approved Phase III trials of a synthetic biological drug treatment for severe COVID-19, carrimycin. In earlier trials, the treatment was able to help patients hospitalised with severe COVID-19 symptoms recover within 14 days.


Carrimycin is an antibiotic that also has anti-viral, anti-inflammatory and anti-fibrosis effects. It was originally developed in China by the Tonglian Group to treat community-acquired infections in adults caused by sensitive bacteria.


Early in 2020, the company reported that carrimycin can inhibit the replication of SARS-CoV-2 (the virus that causes COVID-19) 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 recognised by the FDA.

Jiang Enhong, Chief Executive Officer at 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 hospitalised with a serious case of COVID-19.”


The international, multi-centre Phase III trial will start in January 2021 and will run for six months. It will be conducted at sites in the US, Argentina, Brazil, Colombia, India, Mexico, Peru, Philippines and Ukraine, dependent on how the pandemic evolves. The trial will involve 300 patients, half in the experimental group and half in the control group.


Enhong added that carrimycin is unique, because of its combined mechanisms of action. According to the CEO, its combination of antibiotic, anti-viral, anti-inflammatory and anti-fibrotic effects means it is highly potent and also avoids the potential harmful