Innovative drug, Carrimycin, Receives FDA Approval for International, Multi-country Phase III Clinical Trial for the treatment of severe COVID-19 in hospitalized patients

• Shenyang Tonglian Group Co., Ltd. announces FDA approval for a randomized, multicenter, placebo-controlled, double-blind clinical study of the safety and efficacy of Carrimycin for the treatment of severe COVID-19 in hospitalized patients
• International 300-patient study, to start in January 2021 and run for ~6 months in the USA, Mexico, Brazil, Philippines, Ukraine, Argentina, Peru, Colombia and India
• Carrimycin is an innovative drug marketed in China, shown in China to have a positive impact on outcome for hospitalized COVID-19 patients with potential significant advantages
• Carrimycin is an innovative, safe and effective compound, administered as film-coated tablet

Shenyang, China – 23 December 2020 …. Shenyang Tonglian Group Co., Ltd. (‘Tonglian Group’ or the company), a company innovating and producing specialty pharmaceuticals including anti-infective treatments, today announces that the U.S. Food & Drug Administration (FDA) has approved a randomized, multicenter, placebo-controlled, double-blind clinical study of the safety and efficacy of Carrimycin for the treatment of severe COVID-19 in hospitalized patients.

The trial (‘Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients’ NCT04672564) is estimated to start in early January 2021 and will be conducted in the USA, Mexico, Brazil, Philippines, Ukraine, Argentina, Peru, Colombia and India. The primary endpoints for the study will be efficacy and safety, being the recovery rate defined as the proportion of patients alive without need for supplementary oxygen and ongoing medical care at Day 28. A number of secondary efficacy and safety endpoints will also be evaluated. The study protocol is available online at clinicaltrials.gov.

Carrimycin is a member of the macrolide family of antibiotics produced from a genetically engineered strain of S. spiramyceticus, using synthetic biology. It received marketing approval in China in June 2019 to treat bacterial infections. Early in the SARS-CoV-2 outbreak in China, Carrimycin was shown in three sequential clinical trials to effectively eliminate SARS-CoV-2 virus in a timely fashion, significantly improve clinical symptoms and pulmonary inflammation, shorten hospitalization time, and improve patient prognosis. 

The Ministry of Science and Technology of the People's Republic of China has mentioned Carrimycin as a safe and effective domestic drug for treating COVID-19.

The International trial will enrol 300 hospitalized patients ≥18 years including 150 patients in the experimental group and 150 patients in the control group. Anticipated to last about six months, an interim analysis is planned to be conducted when half (~150) patients have completed the 28-day assessment period. Under the study protocol, Carrimycin will be administered as 2x 200mg film-coated tablets once daily for 14 days.

Carrimycin is China's first innovative drug independently developed by the Institute of Medical Biotechnology, Chinese Academy of Medical Sciences and Tonglian Group using synthetic biology. It is the only FDA-approved synthetic biology drug in the world for phase III clinical studies of severe coronavirus disease.

Commenting on the forthcoming FDA-approved International trial of Carrimycin Jiang Enhong, CEO at Tonglian Group said:

“Our company is proud to have been actively supporting the anti-SARS-CoV-2 pre-clinical and clinical emergency initiatives in China. In view of the seriousness of the pandemic, Tonglian Group is keen to explore the potential of Carrimycin on the international stage to contribute to the global fight against COVID-19.

“We are delighted that having completed its safety review, the FDA has approved our application for a clinical study of the safety and efficacy of Carrimycin for the treatment of severe COVID-19 in hospitalized patients.”

Zhao Xiaofeng, Head of New Drug Development Department at Tonglian Group added:

“Carrimycin is cost effective to produce at scale, and easily administered as a simple tablet. Based on the very positive Chinese studies to date, and our understanding of the potential mode of action of Carrimycin, we believe it could have a very important role to play in improving the outcome of patients with moderate to severe COVID-19.”

According to research by the Chinese Academy of Medical Sciences and other research institutes, the anti-replication effect of Carrimycin on coronavirus in vitro is much stronger than that of Azithromycin. It has also found the target for the protein synthesis inhibition effect of Carrimycin, via the mTOR pathway, and the inhibitory effect of Carrimycin on this protein, is stronger than those of other macrolide drugs and that Carrimycin has a good antifibrosis effect.

“Carrimycin will be used in the clinical trial of COVID-19 as a single drug application, rather than combined with other antiviral drugs, it may avoid drug interaction caused by drug combination” Dr. Xia Mingyu from Shenyang Pharmaceutical University added.